Depuy Mitek A Johnson And Johnson recalls
Depuy Mitek A Johnson And Johnson appears in 51 official U.S. recall notices indexed by RecallRadar, most recently on 2025-03-19.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 51 |
|---|---|
| Published | 2012-07-11 to 2025-03-19 |
| By agency | FDA Device (51) |
| By classification | Class II (51) |
| By status | terminated (44), ongoing (7) |
| Distribution named in notices | AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, ND, NE, NH, NJ, NM, OH, OK, OR, PA, TN, TX, US, VA, WA, WI |
Recalls
- COR Disposable Kit, 8 mm w/ Perpendicularity
FDA Device · Class II · 2025-03-19 · Depuy Mitek A Johnson And Johnson
Reason: Device is missing the pin in the graft loader component. - COR Disposable Kit, 8 mm
FDA Device · Class II · 2025-03-19 · Depuy Mitek A Johnson And Johnson
Reason: Device is missing the pin in the graft loader component. - DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobiliz…
FDA Device · Class II · 2023-06-14 · Depuy Mitek A Johnson And Johnson
Reason: IFU 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 BIOKNOT… - DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobiliza…
FDA Device · Class II · 2023-06-14 · Depuy Mitek A Johnson And Johnson
Reason: IFU 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 BIOKNOT… - DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilizat…
FDA Device · Class II · 2023-06-14 · Depuy Mitek A Johnson And Johnson
Reason: IFU 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 BIOKNOT… - DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immob…
FDA Device · Class II · 2023-06-14 · Depuy Mitek A Johnson And Johnson
Reason: IFU 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 BIOKNOT… - DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immo…
FDA Device · Class II · 2023-06-14 · Depuy Mitek A Johnson And Johnson
Reason: IFU 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 BIOKNOT… - Healix Knotless ADV BR 4.75 Suture Anchor
FDA Device · Class II · 2019-12-18 · Depuy Mitek A Johnson And Johnson
Reason: Specific 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 biocom… - Healix Knotless ADV BR 5.5 Suture Anchor
FDA Device · Class II · 2019-12-18 · Depuy Mitek A Johnson And Johnson
Reason: Specific 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 biocom… - Mitek Screw and Washer Depth Gauge, Product Code 219024
FDA Device · Class II · 2018-10-31 · Depuy Mitek A Johnson And Johnson
Reason: 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. - LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the ort…
FDA Device · Class II · 2018-05-16 · Depuy Mitek A Johnson And Johnson
Reason: Reports of product loosening or coming unscrewed from the handle. - 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers…
FDA Device · Class II · 2018-03-07 · Depuy Mitek A Johnson And Johnson
Reason: Leakage of FMS gravity tub sets (281113) at the bulb and tube connection - DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat…
FDA Device · Class II · 2017-06-28 · Depuy Mitek A Johnson And Johnson
Reason: 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 - DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat rec…
FDA Device · Class II · 2017-06-28 · Depuy Mitek A Johnson And Johnson
Reason: 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 - DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Screw set is intended to t…
FDA Device · Class II · 2017-06-28 · Depuy Mitek A Johnson And Johnson
Reason: 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 - DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurr…
FDA Device · Class II · 2017-06-28 · Depuy Mitek A Johnson And Johnson
Reason: 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 - DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat…
FDA Device · Class II · 2017-06-28 · Depuy Mitek A Johnson And Johnson
Reason: 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 - FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades
FDA Device · Class II · 2016-01-27 · Depuy Mitek A Johnson And Johnson
Reason: Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label. - FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades
FDA Device · Class II · 2016-01-27 · Depuy Mitek A Johnson And Johnson
Reason: Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label. - FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades
FDA Device · Class II · 2016-01-27 · Depuy Mitek A Johnson And Johnson
Reason: Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label. - VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
FDA Device · Class II · 2015-12-30 · Depuy Mitek A Johnson And Johnson
Reason: Mitek 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 impac… - DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Syst…
FDA Device · Class II · 2013-11-20 · Depuy Mitek A Johnson And Johnson
Reason: 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 of irrigation fluid into the One Day Set which may potentially lead to… - DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS¿ Fluid Managemen…
FDA Device · Class II · 2013-11-20 · Depuy Mitek A Johnson And Johnson
Reason: 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 of irrigation fluid into the One Day Set which may potentially lead to… - DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instr…
FDA Device · Class II · 2013-05-15 · Depuy Mitek A Johnson And Johnson
Reason: Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration. - ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114
FDA Device · Class II · 2013-05-01 · Depuy Mitek A Johnson And Johnson
Reason: The 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… - ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116
FDA Device · Class II · 2013-05-01 · Depuy Mitek A Johnson And Johnson
Reason: The 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… - ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111
FDA Device · Class II · 2013-05-01 · Depuy Mitek A Johnson And Johnson
Reason: The 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… - ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115
FDA Device · Class II · 2013-05-01 · Depuy Mitek A Johnson And Johnson
Reason: The 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… - ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223113
FDA Device · Class II · 2013-05-01 · Depuy Mitek A Johnson And Johnson
Reason: The 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… - DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and…
FDA Device · Class II · 2012-12-26 · Depuy Mitek A Johnson And Johnson
Reason: 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 reamer - SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision - SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision - SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rot…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision - SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rot…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision - SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in ro…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision - SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in ro…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision - DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for u…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: 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 electrode - Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair sur…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision - SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 SPIRALOK Anchors are primarily used to re-attach soft tiss…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision - SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotato…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision - SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotato…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision - SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rot…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision - SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987 SPIRALOK Anchors are primarily used to re-attach soft tissue t…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision - SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 SPIRALOK Anchors are primarily used to re-attach soft tiss…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision - SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision - SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rot…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision - SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985 SPIRALOK Anchors are primarily used to re-attach soft tissue t…
FDA Device · Class II · 2012-10-31 · Depuy Mitek A Johnson And Johnson
Reason: Fracture of SPIRALOK Anchors post op, requiring patient revision - Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413
FDA Device · Class II · 2012-07-11 · Depuy Mitek A Johnson And Johnson
Reason: Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles - Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411
FDA Device · Class II · 2012-07-11 · Depuy Mitek A Johnson And Johnson
Reason: Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles - Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611
FDA Device · Class II · 2012-07-11 · Depuy Mitek A Johnson And Johnson
Reason: Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles