Depuy Mitek
FDA adverse event reports naming Depuy Mitek as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: DEPUY MITEK.
- Total reports
- 6,909
- Deaths
- 2
- Injuries
- 2,717
- Malfunctions
- 4,158
Reports per year
Source: FDA adverse event reports by year received, 2007–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- ArthroscopeHRX1,307
- Fastener, Fixation, Nondegradable, Soft TissueMBI1,259
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI1,246
- Fastener, Fixation, Biodegradable, Soft TissueMAI1,032
- Orthopedic Manual Surgical InstrumentLXH711
- Screw, Fixation, BoneHWC472
- Bit, DrillHTW163
- Applier, Staple, Surgical,GEF122
- Staple, Fixation, BoneJDR121
- Accessories, ArthroscopicNBH67
Recent recalls
- 2025-03-11Open, ClassifiedEmployee error
COR Disposable Kit, 8 mm. Cartilage Transplant System.
Device is missing the pin in the graft loader component.
- 2025-03-11Open, ClassifiedEmployee error
COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
Device is missing the pin in the graft loader component.
- 2023-06-02Open, ClassifiedUse error
DePuy 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
- 2023-06-02Open, ClassifiedUse error
DePuy 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
- 2023-06-02Open, ClassifiedUse error
DePuy 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
- 2023-06-02Open, ClassifiedUse error
DePuy 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
- 2023-06-02Open, ClassifiedUse error
DePuy 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
- 2016-01-15TerminatedProcess control
FMS neXtra 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
- 2016-01-15TerminatedProcess control
FMS neXtra 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
- 2016-01-15TerminatedProcess control
FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
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