DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
16 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (16)
Registered facilities (1)
- DePuy Mitek, Inc. FEI 1221934 · MA
Recalls & enforcement
20251 record
- Class IIOngoing2025-02-24Device is missing the pin in the graft loader component.
20231 record
- Class IIOngoing2023-04-13IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS® Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS® Anchor inserter tip detected during surgery may require…
20191 record
- Class IITerminated2019-11-04Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE® Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, inject…
20181 record
- Class IITerminated2018-08-30The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.
20173 records
- Class IITerminated2017-12-22Reports of product loosening or coming unscrewed from the handle.
- Class IITerminated2017-08-31Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
- Class IITerminated2017-05-12Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
20152 records
- Class IITerminated2015-11-23Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each button function was confirmed as correct and the non-conformance impacted button color only
- Class IITerminated2015-11-20Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
20133 records
- Class IITerminated2013-08-29Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo intermediary tubing set may not perform as intended. may result in backflow of irrigation fluid into the One Day Set which may potentially lead to patient cross-contamination
- Class IITerminated2013-04-15Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
- Class IITerminated2013-03-22The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sut…
20124 records
- Class IITerminated2012-11-16Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, 7 units were labeled as 11MM while the box actually contained a 10 MM reamer
- Class IITerminated2012-09-06Fracture of SPIRALOK Anchors post op, requiring patient revision
- Class IITerminated2012-05-04Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
- Class IITerminated2012-03-12Product may have wrong large product identification label with symbols on the box indicating a S90 VAPR Electrode instead of the VAPR 3.5 hook electrode
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “DEPUY MITEK, A JOHNSON & JOHNSON COMPANY — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-1221934-depuy-mitek-a-johnson-johnson-company/
Alerts for DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
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.
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.