Facility

SMITH & NEPHEW INC.

101 recall(s) on record — most severe on record: Class II.

Key facts

101recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1643264
Establishment type	Manufacture Medical Device
Location	ENDOSCOPY OKLAHOMA CITY, OK, US 73107
Registration status	Active · expires 2026
Parent company	Smith & Nephew, Inc. (owner-operator 1020279)
Brand names	ENDOBUTTON; ROUND ENDOBUTTON 2-HOLE WITH POST SST WITH SZ3/4 SUTURE LOOP; ROUND ENDOBUTTON 1-HOLE SST FOR SZ3/4 SUTURE LOOP; ROUND ENDOBUTTON 2-HOLE SST; ROUND ENDOBUTTON 2-HOLE W/POST SST

Activity by year

Recalls (101)
Inspections (1)

Devices registered here (2)

Washer, Bolt Nut
Product code HTN (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3030
Screw, Fixation, Bone
Product code HWC (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3040

Recalls & enforcement

20261 record

Class IIOngoing2026-03-16
Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent nail of the same size, which would require additional surgical…

20252 records

Class IIOngoing2025-11-24
Removal of affected lot of screws due to labeling error.
Class IIOngoing2025-03-18
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.

20247 records

Class IIOngoing2024-10-29
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Class IIOngoing2024-10-15
The Bipolar assembly contains an oversized Retainer Ring.
Class IIOngoing2024-10-02
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
Class IIOngoing2024-10-02
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
Class IIOngoing2024-08-12
Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
Class IIOngoing2024-07-09
Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.
Class IIOngoing2024-04-24
Packaging contained the incorrect size of femoral head from what was displayed on the label.

20235 records

Class IIOngoing2023-09-27
The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.
Class IIOngoing2023-08-31
The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.
Class IIOngoing2023-07-24
A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.
Class IIOngoing2023-05-02
Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk …
Class IIOngoing2023-03-27
A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.

20223 records

Class IITerminated2022-06-27
The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.
Class IITerminated2022-04-19
It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.
Class IIOngoing2022-01-04
The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw

20216 records

Class IIOngoing2021-12-14
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
Class IITerminated2021-11-01
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.
Class IIOngoing2021-10-25
The labels on the packages of screws were switched.
Class IITerminated2021-09-20
The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.
Class IITerminated2021-05-19
The device components experienced a manufacturing process error that resulted in surface damage from product handling.
Class IITerminated2021-04-08
Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw

202016 records

Class IITerminated2020-12-18
Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.
Class IITerminated2020-11-02
Manufacturing packaging error.
Class IITerminated2020-09-21
The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation.
Class IITerminated2020-09-21
The anterior locking detail does not meet its design specifications.
Class IIOngoing2020-09-09
Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
Class IITerminated2020-08-24
Multiple or incorrect expiration dates were provided on the affected designation labels.
Class IITerminated2020-08-03
The products were improperly heat treated.
Class IIOngoing2020-07-16
Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.
Class IITerminated2020-06-29
The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part.
Class IIOngoing2020-06-24
A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.
Class IIOngoing2020-06-24
The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve
Class IITerminated2020-06-24
A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.
Class IIOngoing2020-04-22
A manufacturing error resulted in out of specification R3 Acetabular Shells
Class IIOngoing2020-03-17
Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach.
Class IITerminated2020-02-27
Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.
Class IITerminated2020-01-28
The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.

20197 records

Class IITerminated2019-12-30
Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the steril…
Class IITerminated2019-12-19
LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
Class IIOngoing2019-12-16
Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.
Class IITerminated2019-11-11
There is a a potential failure mode associated with the use of the mallet, wherein the poly tip of the mallet may become loose and/or come off during use. If the potential failure mode occurs, particles generated in the poly thread potentially could enter the surgical field or a …
Class IITerminated2019-10-07
LAG SCREW 3.2 GUIDE PIN SLEEVE are being recalled due to a manufacturing error. The detent balls in the guide pin sleeve were not drilled to the correct depth, which will cause them to not fully compress.
Class IITerminated2019-02-19
Complaints were received indicating that the outer label incorrectly identified the product as size "1" instead of "-1". The product contained within the package is size "-1"
Class IITerminated2019-01-07
The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.

201811 records

Class IITerminated2018-12-10
Higher than anticipated occurrence of bone fracture during the use of the XR Tibia Posterior Punch
Class IITerminated2018-09-18
One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring.
Class IIOngoing2018-06-13
The data in the National Joint Registry of England, Wales and Northern Ireland (NJREWNI) and Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) indicate that the first generation JOURNEY BCS Knee System has a revision rate over 1.5 times the primary …
Class IITerminated2018-05-11
The affected devices are manufactured to the same design specification as products intended for sale and use in the US but do not contain the FDA approved labeling (i.e., IFU and Patient Information Brochure). The affected devices were distributed in the US with the IFU intended …
Class IITerminated2018-05-04
One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.
Class IITerminated2018-05-02
Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.
Class IITerminated2018-04-09
A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa.
Class IITerminated2018-03-30
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Class IITerminated2018-03-07
One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch.
Class IITerminated2018-02-01
The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5.
Class IICompleted2018-01-15
The affected products were inadvertently packaged with an incorrect screw component.

201715 records

Class IITerminated2017-12-13
In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the frame is generated by the software. The frame will appear inverted in the preview images on the Strut Settings tab.
Class IITerminated2017-12-11
Devices, incorrectly labeled as a VLP MINI-MOD 2.0MM STRAIGHT PLATE 8 HOLE, contained a VLP MINI-MOD 2.0MM STOUT PLATE 8 HOLE and vice versa
Class IITerminated2017-12-11
Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.
Class IITerminated2017-11-29
One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.
Class IIOngoing2017-10-24
A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
Class IITerminated2017-10-23
The expiration date provided on the label is incorrect.
Class IITerminated2017-09-14
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
Class IITerminated2017-08-01
Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.
Class IITerminated2017-07-24
The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
Class IITerminated2017-05-30
The incorrect Loctite adhesive was used to assemble the impactor heads.
Class IITerminated2017-03-30
The stability data does not support the product labeled with a 10-year shelf life.
Class IITerminated2017-03-22
This lot of left plates were laser etched and packaged as right plates.
Class IITerminated2017-03-15
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
Class IITerminated2017-03-09
The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.
Class IITerminated2017-02-02
The single use devices are provided sterile and do not have an expiration date on the label.

201610 records

Class IITerminated2016-11-16
The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.
Class IITerminated2016-11-15
All lots of modular neck hip prostheses are being recalled due to a higher than anticipated complaint and adverse event trend.
Class IITerminated2016-08-29
Some Bipolar shells were manufactured with an out of specification retainer groove.
Class IITerminated2016-07-19
Sterility compromised due to breach in sterile packaging
Class IITerminated2016-07-06
The labels correctly state that the product should be a 25mm screw, but the box contained a longer, 35mm screw.
Class IITerminated2016-06-15
The device could be subject to breaches of its sterile packaging.
Class IITerminated2016-05-26
The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
Class IITerminated2016-03-11
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.
Class IITerminated2016-01-18
The package for catalog item, a LEGION Hemi Stepped Tibial Wedge, 5 MM Size 5-6 LT-LAT/ RT-MDL, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. A complaint was received indicating that the screws pac…
Class IITerminated2016-01-11
Blade exhibiting fracture during hip arthroscopy procedures

20156 records

Class IITerminated2015-11-16
The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing in the US. The actual devices were monoblock Modular Femoral Head for hemiarthroplasty use.
Class IITerminated2015-11-09
One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.
Class IITerminated2015-10-20
The devices were packaged and laser marked anatomically incorrect. The Left plates were laser marked and packaged as Right plates and the Right plates were laser marked and packaged as Left plates.
Class IITerminated2015-06-03
The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
Class IITerminated2015-05-06
The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
Class IITerminated2015-04-30
Sterility of device maybe compromised

20144 records

Class IITerminated2014-11-04
The stem taper on this device is undersized; the gauge point is not deep enough.
Class IITerminated2014-07-02
There was an error in manufacturing which resulted in the proximal lag screw hole being positioned incorrectly in several batches of TRIGEN(R); INTERTAN(TM); NAILS.
Class IITerminated2014-04-04
A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
Class IITerminated2014-01-23
Inner spherical radius of the shell is undersized.

20137 records

Class IITerminated2013-11-25
One batch of the Reflection(TM) Polyethylene Acetabular Liners may be out of tolerance causing the liner not to fully seat into the shell.
Class IITerminated2013-10-07
Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
Class IITerminated2013-08-27
The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.
Class IITerminated2013-07-08
The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).
Class IITerminated2013-05-29
One batch of 60 mm 20o R3 XLPE liner may be laser etched and packaged as a 62 mm 20o liner and one batch of 62 mm 20o R3 XLPE liner may be laser etched and packaged as a 60 mm 20o liner.
Class IITerminated2013-03-06
One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).
Class IITerminated2013-02-07
75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.

20121 record

Class IITerminated2012-08-22
Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.

FDA inspections (1)

NAI2017-08-21
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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.

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. “SMITH & NEPHEW INC. (FEI 1643264) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1643264-smith-nephew-inc/

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