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DePuy Mitek, Inc., a Johnson & Johnson Recalls
51 recalls on record · July 11, 2012 to March 19, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 19, 2025Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
Hazard: Device is missing the pin in the graft loader component.
March 19, 2025Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls COR Disposable Kit, 8 mm. Cartilage Transplant System.
Hazard: Device is missing the pin in the graft loader component.
June 14, 2023Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate post
Hazard: 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 BIOKNOTLESS¿ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
June 14, 2023Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate posto
Hazard: 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 BIOKNOTLESS¿ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
June 14, 2023Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postop
Hazard: 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 BIOKNOTLESS¿ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
June 14, 2023Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate
Hazard: 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 BIOKNOTLESS¿ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
June 14, 2023Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate
Hazard: 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 BIOKNOTLESS¿ Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time
December 18, 2019Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls Healix Knotless ADV BR 5.5 Suture Anchor
Hazard: 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 biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.
December 18, 2019Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls Healix Knotless ADV BR 4.75 Suture Anchor
Hazard: 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 biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.
October 31, 2018Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls Mitek Screw and Washer Depth Gauge, Product Code 219024
Hazard: 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.
May 16, 2018Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intende
Hazard: Reports of product loosening or coming unscrewed from the handle.
March 7, 2018Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from
Hazard: Leakage of FMS gravity tub sets (281113) at the bulb and tube connection
June 28, 2017Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw se
Hazard: 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
June 28, 2017Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is i
Hazard: 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
June 28, 2017Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek LATARJET EXPERIENCE Coracoid Top Hat Drill Product Code: 288202 Product Usage: The Latarjet Cortical Scre
Hazard: 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
June 28, 2017Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is
Hazard: 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
June 28, 2017Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw
Hazard: 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
January 27, 2016Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving
Hazard: Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
January 27, 2016Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shavi
Hazard: Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
January 27, 2016Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, sha
Hazard: Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
December 30, 2015Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls VAPR¿ TRIPOLAR 90" Degree Suction Electrodes (Model/Catalog No: 225028)
Hazard: 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 impacted button color only
November 20, 2013Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek FMS Outflow Tubing with One-Way valve Product Code:284649 Product Usage: The Intermediary Tubing for FM
Hazard: 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 patient cross-contamination
November 20, 2013Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing
Hazard: 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 patient cross-contamination
May 15, 2013Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, no
Hazard: Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
May 1, 2013Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116.
Hazard: 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 is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six
May 1, 2013Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in
Hazard: 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 is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six
May 1, 2013Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use i
Hazard: 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 is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six
May 1, 2013Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223113. For use in general
Hazard: 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 is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six
May 1, 2013Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approxim
Hazard: 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 is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six
December 26, 2012Medical DevicesFDA
DePuy Mitek, Inc., a Johnson & Johnson Co. recalls DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cu
Hazard: 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