Facility
ZIMMER SURGICAL, INC.
122 recall(s) on record — most severe on record: Class I.
Activity by year
- Recalls (122)
- Inspections (1)
Devices registered here (1)
- Apparatus, Suction, Ward Use, Portable, Ac-PoweredProduct code JCX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4780
Recalls & enforcement
20263 records
- Class IIOngoing2026-05-20Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- Class IIOngoing2026-05-11Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
- Class IIOngoing2026-03-30Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to …
20256 records
- Class IIOngoing2025-12-02Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage nec…
- Class IIOngoing2025-09-26Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E® Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
- Class IIOngoing2025-03-24The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
- Class IIOngoing2025-02-27The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.
- Class IIOngoing2025-02-12There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.
- Class IIOngoing2025-01-06It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly for three units within the scope.
20245 records
- Class IIOngoing2024-09-17A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of the endoscope slot to the end of the tail piece. This allows the scope to move further into the plastic sheath that runs the length of the device, resulting in an interfere…
- Class IIOngoing2024-08-08Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
- Class IIOngoing2024-07-02Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.
- Class IIOngoing2024-03-28Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.
- Class IIOngoing2024-03-20Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock, may result in delay in surgery or loss of fixation resulting fur…
20234 records
- Class IIOngoing2023-07-26The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
- Class IIOngoing2023-06-27Thread form issue of the locking holes in that the locking screws would not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock.
- Class IITerminated2023-05-19Device outer packaging was incorrectly labeled.
- Class IIOngoing2023-02-27Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degr…
20223 records
- Class IIOngoing2022-12-07Two planers were found to be unusable during sawbones shoulder training.
- Class IIOngoing2022-12-06Zimmer Biomet is conducting a voluntary medical device recall related to the NexGen Stemmed Option Tibial Components due to the clinically and statistically significant higher overall revision rates when these tibial components are used with either the Legacy Posterior Stabilized…
- Class IIOngoing2022-08-25The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical inter…
20211 record
- Class IITerminated2021-05-07Zimmer Natural Nail (ZNN) System-CMN Femoral Nail potential commingle between CCD angle 130 degree and 125 degree
20192 records
- Class IITerminated2019-08-21Incorrect labeling on the products package. The label on the package shows size 50-18 whereas the implant inside the packaging size 40-14.
- Class IITerminated2019-04-08An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
20183 records
- Class IITerminated2018-10-31Mislabeled Labeled Avenir Mller Stem size 1, the stem inside the packaging is an Avenir Mller Stem size 2 .
- Class IITerminated2018-03-15Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use.
- Class IITerminated2018-02-28A potential commingle that could result in the product in the package not matching the product on the outer label.
20171 record
- Class IITerminated2017-05-11the devices used a different raw material to produce two countersink products which has higher hardness and higher carbon content resulting in device damage.
20163 records
- Class IITerminated2016-06-30Product mix-up. The Avenir Mller Stem 6 lateral uncemented might be placed in the packaging of the Avenir Mller Stem 4 standard uncemented and vice versa. Potential for delay in surgery, and/or potential for use of incorrect implant which may in turn lead dismetry in patien…
- Class IITerminated2016-06-27Zimmer Biomet initiated a voluntary recall of the Twist Drill & V-Tek Twist Drill due to to a potential tolerance stack up identified between the twist drill and the mating Kirschner Wire (K-Wire) component.
- Class IITerminated2016-05-17In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken ou…
201514 records
- Class IITerminated2015-11-24Complaints that the ratchet teeth of the tube are not latching onto the rod.
- Class IITerminated2015-11-10The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
- Class IITerminated2015-09-03In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or during a surgery by the user, it may lead t…
- Class IITerminated2015-08-27Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these same guide wires.
- Class IITerminated2015-08-11It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk screening as applied by the supplier. The T-plate catalog numbers noted in the tray are listed as …
- Class IITerminated2015-06-17A single distributed ZNN Greater Trochanter Femoral Nail may have been dented. Potential for fatigue of implant prior to sufficient fracture healing, which may result in need for implant removal and revision of fracture fixation to assure proper healing and avoid fracture maluni…
- Class ITerminated2015-05-18Zimmer is initiating a voluntary recall of 64 lots (752 implants total) of M/L Taper with Kinectiv® femoral stems and modular necks due higher than allowed cytotoxicity levels found with the product. Reasonable probability of adverse biological response and subsequent revision
- Class IITerminated2015-04-30Potential for uncured adhesive between the metal threaded insert and the impactor block to leak out of the assembled part following the autoclave sterilization process. The Master Bond epoxy serves as a secondary locking mechanism to fix the metal insert to the impactor head. For…
- Class IITerminated2015-04-29The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with the M/DN system. This has the potential to lead to a situation in which the screw would bind upon entering the nail and have to be removed during the surgery or removal of …
- Class IITerminated2015-04-02The affected lot is being recalled because it was packaged without the locking screw. The locking screw packaged with the augment is used to fix the augment to the femoral component. This has the potential to delay surgery
- Class IITerminated2015-03-18Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery.
- Class IITerminated2015-03-10Zimmer, Inc is voluntarily recalling 22 lots of Persona® Anterior Referencing Sizer with Locking Boom, part number 42-5099-088-10. Devices are being removed from distribution due to nonconforming to print specifications.
- Class IITerminated2015-02-05PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.
- Class IITerminated2015-01-28An increase in complaints of loosening and radiolucent lines.
201430 records
- Class IITerminated2014-12-17Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to …
- Class IITerminated2014-12-11Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. To prevent this, TASP shims must be manually cleaned and inspected per product insert, 87-6203-991…
- Class IITerminated2014-12-08Samples of product from Supplier lot 14D0809 and 14D0808 showed little adhesive transfer between the Tyvek lid and cavity when opened for internal bone cement cure and pairing tests. Visually these samples do not meet the requirements of ZWI 43.109 and corresponding visual aid 55…
- Class IITerminated2014-12-04The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. Zimmer received one complaint indicating the magnet cover of a Persona Cemented Tibial Broach Inserter/Extractor Handle lot 62085420 was missing after broachi…
- Class IITerminated2014-11-25Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x 3.5mm in size. Retained tip may result in: pain, soft tissue irritation, soft tissue damage, or increased wear due to contact with the fractured tip; Revision surgery to remove the fr…
- Class IITerminated2014-10-14To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.
- Class IITerminated2014-10-09Cleaning process validation failure.
- Class IITerminated2014-10-07Affected product did not undergo heat treatment hardening step leading to the potential for deformation of the tip.
- Class IITerminated2014-10-02Failed to meet established requirements for sterile barrier integrity due to a breach of the inner cavity. If the outer tray is compromised in addition to the inner tray a periprosthetic infection may occur. The risk associated with a periprosthetic infection is a revision or po…
- Class IITerminated2014-10-01The affected products are missing polar boss threads.
- Class IITerminated2014-09-09The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver.
- Class IITerminated2014-08-07Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical tech…
- Class IITerminated2014-07-30Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. These five forgings were not segregated and were subsequently issued to final manufacturing under Part 00-5926-014-01; lot 62455332. …
- Class IITerminated2014-07-30Persona Distal Valgus Alignment guide collet locks are seizing in the 'unlocked' position.
- Class IITerminated2014-07-23The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
- Class IITerminated2014-07-22Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
- Class IITerminated2014-07-22Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping t…
- Class IITerminated2014-07-17Zimmer Dental is recalling the Tapered Screw-Vent Implant because the inner vial state "03.7 x 8mm" instead of "04.7 x 8 mm."
- Class IITerminated2014-07-10Zimmer received a trend of complaints indicating corrosion of product.
- Class IITerminated2014-07-01The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orientation. The drill bracket and drill guide are not the correct geometry to allow for a prope…
- Class IITerminated2014-07-01Zimmer is initiating a voluntary recall of 20 production lots of Moore Hip Prosthesis Long Fenestrated Stems due to packaging design verification test failures. Specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the Moore hip stem breached …
- Class IITerminated2014-06-25Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial.
- Class IITerminated2014-06-10A complaint was received in which it was reported that an 8-hole plate from lot 62276042 had an enlarged hole that is unable to lock the screw, which resulted in the screw head pulling through plate hole.
- Class IITerminated2014-05-23Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
- Class IITerminated2014-05-19Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
- Class IITerminated2014-05-19During routine inspection, beaded hip stem forgings received from supplier failed to meet ZES 2A-102. Processing of Beaded CoCrMo Alloy Hip Stem, material requirements per ATS #14-04818 and ATS #14-05549, respectively.
- Class IITerminated2014-04-01The shell was missing the locking ring.
- Class IITerminated2014-03-19During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
- Class IITerminated2014-02-25A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container expos…
- Class IITerminated2014-01-10This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond strength approximately 80% of the minimum required by specification in one of the three zo…
201326 records
- Class IITerminated2013-12-19After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethyle…
- Class IITerminated2013-12-10Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct.
- Class IITerminated2013-11-19This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these devices to be inadvertently utilized during surgery, resulti…
- Class IITerminated2013-11-12As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants. The specific material was f…
- Class IITerminated2013-11-05Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testi…
- Class IITerminated2013-11-04The patient label associated with the product may be incorrect in that the lot number on the patient label may be different than the lot number on the outer carton label.
- Class IITerminated2013-10-31Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose. The taper diameter was found to be ove…
- Class IITerminated2013-10-17As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to properly assemble the Glenosphere to the Baseplate.
- Class IITerminated2013-10-11Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility …
- Class IITerminated2013-10-09Zimmer Spine, Inc. is initiating a correction regarding the Trinica ALP Instrument Tray, part 07.01058.001 (all lots). The Ratchet Handles, part 07.00438.001 may not be effectively sterilized if left in their designated location(s) in the instrument tray. This is due to the cur…
- Class IITerminated2013-08-30The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
- Class IITerminated2013-08-28Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for steri…
- Class IITerminated2013-08-28Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the establishe…
- Class IITerminated2013-08-26Possibility of the weld to the quick-connect breaking when force is applied to the handle for pedicle screw removal. A broken weld could lead to the use of an alternate method of screw removal, which could delay surgery up to 30 minutes.
- Class IITerminated2013-08-01Zimmer is initiating a lot specific recall of the Trabecular Metal" Reverse Glenosphere Distractor due to the potential of the device not functioning properly should it be utilized without proper lubrication. As a result, there is a potential for the device to fail to provide imp…
- Class IITerminated2013-07-30Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, Short due to the incorrect information printed on the Chinese label. The original label indicates that implants are RIGHT sided, but the Chinese label indicates that the implants are…
- Class IITerminated2013-07-16Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the establishe…
- Class IITerminated2013-06-28There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. There have been 47 reported complaints of tab fracture.
- Class IITerminated2013-06-19Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product.
- Class IITerminated2013-06-11The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices.
- Class IITerminated2013-06-10Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.
- Class IITerminated2013-06-07Surgeons are implanting components of the NexGen Cruciate Retaining (CR) Complete Knee System in combinations that are not approved (micro with standard). Includes CR Micro Femurs, Articular Surface, Patellae, instruments and provisionals combined with standard components. A Marc…
- Class IITerminated2013-05-23This is a recall expansion from the 2010 recall which now includes seven additional lots that were not previously included. Zimmer, Inc. is initiating a recall of small and large Fukuda-type retractors due to fractures occurring at the grooves around the perimeter of the blades …
- Class IITerminated2013-03-27Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result, there is a potential for the drill to not pass through the applicable drill guide.
- Class IITerminated2013-02-14The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.
- Class IITerminated2013-02-08Possibility that the inner pouch may be compromised. The product is packaged in two pouches - a sterile inner pouch within an external pouch. NexPosure Retractors contained in a breached inner pouch have an increased risk of contamination (i.e.; loss of product sterility) if prop…
201219 records
- Class IITerminated2012-11-19Zimmer is initiating a lot specific recall because affected lots could include an extra Small Inner Pin instead of the required Regular Inner Pin in the Coonrad/Morrey Elbow Replacement Set and the New Ulnar Revision Kit .
- Class IITerminated2012-11-14All lots of the Persona Cemented Tibial Drill, 5 Degree Cemented Stemmed Natural Tibia implants, and associated tools including the Tibial Drill Guide, Broach, and Sizing Plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perfora…
- Class ITerminated2012-11-12Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of up to 60 minutes could occur. Sharp edges …
- Class IITerminated2012-09-21Zimmer is initiating a lot specific recall of the NexGen® Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing cleaning operation that was operating outside of the validated parameters. As a result, the devices may contain residual p…
- Class IITerminated2012-09-20Zimmer Spine is has received complaints of difficulty in turning the implant release knob of the TM Ardis Inserter after final positioning of the TM Ardis interbody spacer implant. There has been two reports where the inserter instrument was inadvertently removed from patient wi…
- Class IITerminated2012-09-20Zimmer Trilogy® Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Zimmer received one complaint in which no injury was reported.
- Class IITerminated2012-09-14Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
- Class IITerminated2012-09-13Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed international…
- Class IITerminated2012-09-07Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer Persona Personalized Knee System due to three reports being received as of August 29. 2012 for tibial cortex perforation during preparation of the tibial bone. The investigation into the reports that have…
- Class IITerminated2012-09-05Zimmer is conducting a voluntary removal of some Zimmer A.T.S. 3000 tourniquets after receiving complaints of both out-of-box failures and failures during surgical procedures on some of the affected units. During failure the unit will alarm, lock into a non-operational mode, and …
- Class IITerminated2012-09-04Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect …
- Class IITerminated2012-08-31Zimmer Inc. is initiating a removal of the Multipolar® Bipolar Cup Liner 22 mm J.D. (item 00-5001-040-22) due to reports that the split poly ring was incorrectly assembled.
- Class IITerminated2012-08-27Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton.
- Class IITerminated2012-07-18Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, as all reported fractured instruments wer…
- Class IITerminated2012-07-13Zimmer investigation following a complaint found one lot of NCB Polyaxial Locking Plate System NCB screws, 26mm, distributed in the United States contained incorrect 32 mm screws.
- Class IITerminated2012-06-05Zimmer is recalling Pathfinder NXT Fixed Percutaneous Rod Holder, because complaints have been received that the rod holder tip may crack or break when the rod is manipulated during surgery.
- Class IITerminated2012-06-05Complaints have been reported where, during surgery, the surgeon was unable to loosen or remove the inserted rod from the rod holder instrument. The complaint investigation showed the hex mating feature of the set screw was broken and material missing. There were no reports of…
- Class IITerminated2012-05-12Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Catalog number 47-4301-031-00 was actually packaged and labeled as catalog number 47-4307-031-00, lot 62071190.
- Class IITerminated2012-04-30The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off of the instrument during use, and a devi…
20111 record
- Class IITerminated2011-04-01Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Intraop…
20101 record
- Class IITerminated2010-10-10Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods th…
FDA inspections (1)
- VAI2016-05-23Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
- All facilities operated by ZIMMER, INC.
- ZIMMER, INC. (IN)
- ZIMMER CAS (CA)
- ZIMMER SURGICAL SA (CH)
- Zimmer Orthopedic Mfg Ltd (IE)
- Zimmer Trabecular Metal Technology, Inc. (NJ)
- Zimmer Biomet Canada DFE (CA)
- Zimmer Orthopedics Manufacturing Limited-Galway (IE)
- ZIMMER MANUFACTURING B.V. (PR)
- Zimmer U.S., Inc. Connected Health (MI)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “ZIMMER SURGICAL, INC. (FEI 1526350) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1526350-zimmer-surgical-inc/
Not open yet
Alerts for ZIMMER SURGICAL, INC.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Planned
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.