DePuy Mitek, Inc., a Johnson & Johnson Co.
7 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for DePuy Mitek, Inc., a Johnson & Johnson Co. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-03-19FDA-DeviceClass IICOR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
Device is missing the pin in the graft loader component.
- 2025-03-19FDA-DeviceClass IICOR Disposable Kit, 8 mm. Cartilage Transplant System.
Device is missing the pin in the graft loader component.
- 2023-06-14FDA-DeviceClass IIDePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
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
- 2023-06-14FDA-DeviceClass IIDePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
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
- 2023-06-14FDA-DeviceClass IIDePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
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
- 2023-06-14FDA-DeviceClass IIDePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
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
- 2023-06-14FDA-DeviceClass IIDePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
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
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