Recall archive
15 recalls · page 1 of 1
Reported Mar 19, 2025
COR Disposable Kit, 8 mm. Cartilage Transplant System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
Matched: Brand — Device is missing the pin in the graft loader component.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 14, 2023
DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
Matched: Brand · Product · Product details — IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS¿ Anchor Inserter may cause a fragment of the inserter tip…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 18, 2019
Healix Knotless ADV BR 4.75 Suture Anchor
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
Matched: Brand · Reason for recall — Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 31, 2018
Mitek Screw and Washer Depth Gauge, Product Code 219024
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
Matched: Brand · Product · Product details — The device has an offset in the design that results in a reading approximately 3.2mm shorter than the actual length of the bone hole.
FDA (openFDA device enforcement)
Reported May 16, 2018
LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
Matched: Brand — Reports of product loosening or coming unscrewed from the handle.
FDA (openFDA device enforcement)
Reported Mar 7, 2018
1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
Matched: Brand — Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
FDA (openFDA device enforcement)
Reported Jun 28, 2017
DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
Matched: Brand · Product · Product details — Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 27, 2016
FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
Matched: Brand — Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 30, 2015
VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
Matched: Brand · Reason for recall — Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablation and coagulation buttons are colored incorrectly. The wiring for each…
FDA (openFDA device enforcement)
Reported Nov 20, 2013
DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
Matched: Brand · Product · Product details — Pillow 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…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 15, 2013
DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
Matched: Brand · Product · Product details — Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
FDA (openFDA device enforcement)
Reported May 1, 2013
ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
Matched: Brand — The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 26, 2012
DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
Matched: Brand · Product · Product details · Reason for recall — Specific 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…
FDA (openFDA device enforcement)
Reported Oct 31, 2012
DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
Matched: Brand · Product · Product details — Product may have wrong large product identification label with symbols on the box indicating a S90 VAPR Electrode instead of the VAPR 3.5 hook…
16 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 11, 2012
Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.DePuy Mitek, Inc., a Johnson & Johnson Co.
Matched: Brand · Product · Product details — Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
3 more products in this recall
FDA (openFDA device enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up