DePuy Mitek, Inc., a Johnson & Johnson Co.

Complete recall history across all FDA and CPSC categories — 51 total recalls

DePuy Mitek, Inc., a Johnson & Johnson Co. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (51)

FDA medical device enforcement actions by DePuy Mitek, Inc., a Johnson & Johnson Co.. Showing most recent 50.

Date Product Reason Class
Feb 24, 2025 COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System. Device is missing the pin in the graft loader component. Class II
Feb 24, 2025 COR Disposable Kit, 8 mm. Cartilage Transplant System. Device is missing the pin in the graft loader component. Class II
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone... IFU Warning: Applying bending force and/or bending force with impaction to th... Class II
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to... IFU Warning: Applying bending force and/or bending force with impaction to th... Class II
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone ... IFU Warning: Applying bending force and/or bending force with impaction to th... Class II
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone f... IFU Warning: Applying bending force and/or bending force with impaction to th... Class II
Apr 13, 2023 DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to ... IFU Warning: Applying bending force and/or bending force with impaction to th... Class II
Nov 4, 2019 Healix Knotless ADV BR 5.5 Suture Anchor Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors... Class II
Nov 4, 2019 Healix Knotless ADV BR 4.75 Suture Anchor Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors... Class II
Aug 30, 2018 Mitek Screw and Washer Depth Gauge, Product Code 219024 The device has an offset in the design that results in a reading approximatel... Class II
Dec 22, 2017 LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXP... Reports of product loosening or coming unscrewed from the handle. Class II
Aug 31, 2017 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set i... Leakage of FMS gravity tub sets (281113) at the bulb and tube connection Class II
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 ... Combo Screw Driver (Product Code 288211) tip has the increased potential to b... Class II
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 P... Combo Screw Driver (Product Code 288211) tip has the increased potential to b... Class II
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product U... Combo Screw Driver (Product Code 288211) tip has the increased potential to b... Class II
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product... Combo Screw Driver (Product Code 288211) tip has the increased potential to b... Class II
May 12, 2017 DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Pro... Combo Screw Driver (Product Code 288211) tip has the increased potential to b... Class II
Nov 23, 2015 VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028) Mitek identified that on VAPR Tripolar 90 Degree Suction Electrode the ablati... Class II
Nov 20, 2015 FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 ... Product is incorrectly labeled. The blade configuration in the affected lots ... Class II
Nov 20, 2015 FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Inte... Product is incorrectly labeled. The blade configuration in the affected lots ... Class II
Nov 20, 2015 FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 In... Product is incorrectly labeled. The blade configuration in the affected lots ... Class II
Aug 29, 2013 DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Pro... Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo inte... Class II
Aug 29, 2013 DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 ... Pillow valve included in the FMS Duo outflow tubing set and the FMS Solo inte... Class II
Apr 15, 2013 DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusab... Labeled incorrectly as a Blade Up configuration instead of a Blade Down confi... Class II
Mar 22, 2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Ne... The IFU provided with the free strand ORTHOCORD sutures currently indicates t... Class II
Mar 22, 2013 ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Cata... The IFU provided with the free strand ORTHOCORD sutures currently indicates t... Class II
Mar 22, 2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse ... The IFU provided with the free strand ORTHOCORD sutures currently indicates t... Class II
Mar 22, 2013 ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111.... The IFU provided with the free strand ORTHOCORD sutures currently indicates t... Class II
Mar 22, 2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Ne... The IFU provided with the free strand ORTHOCORD sutures currently indicates t... Class II
Nov 16, 2012 DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DeP... Specific units of the DePuy Mitek Sterile Reamers are not labeled correctly, ... Class II
Sep 6, 2012 SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II
Sep 6, 2012 SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRA... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II
Sep 6, 2012 SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II
Sep 6, 2012 SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK ... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II
Sep 6, 2012 SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II
Sep 6, 2012 SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anc... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II
Sep 6, 2012 SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK ... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II
Sep 6, 2012 SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK ... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II
Sep 6, 2012 Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II
Sep 6, 2012 SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 22... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II
Sep 6, 2012 SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II
Sep 6, 2012 SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anc... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II
Sep 6, 2012 SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRA... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II
Sep 6, 2012 SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 22... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II
Sep 6, 2012 SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRA... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II
Sep 6, 2012 SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK ... Fracture of SPIRALOK Anchors post op, requiring patient revision Class II
May 4, 2012 Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confide... Additional Instructions for Use and Surgical Technique for the Confidence Nee... Class II
May 4, 2012 Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement... Additional Instructions for Use and Surgical Technique for the Confidence Nee... Class II
May 4, 2012 Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cemen... Additional Instructions for Use and Surgical Technique for the Confidence Nee... Class II
May 4, 2012 Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confide... Additional Instructions for Use and Surgical Technique for the Confidence Ne... Class II

View all 51 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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