Depuy Mitek, Inc.
325 Paramount Dr, RAYNHAM, MA, US
Registered product codes
82 product codes
Recent MDR events
56 on file
- PERIOSTEAL ELEVATORMar 20, 2026MalfunctionMW5185454
- MILAGRO ADVANCE INTERFERENCE SCREWMay 1, 2025InjuryMW5169758
- EXPRESSEW III W/O HOOK FLEXIBLE SUTURE PASSER REUSABLE SUTURE PASSING DEVICEDec 20, 2024Malfunction20988246
- VAPR TRIPOLAR 90DEGREE SUCTION ELECTRODEMar 25, 2024MalfunctionMW5153144
- DEPUY FLEXIBLE DRILL BITJun 9, 2023MalfunctionMW5118321
- EXPRESSEW III SUTURE NEEDLEJun 9, 2023MalfunctionMW5118333
- HEALIX ADVANCE SP ANCHOR (MITEKAug 26, 2020InjuryMW5096290
- EXPRESSEW NEEDLEJul 23, 2020MalfunctionMW5095689
- DEPUY MITEK MICROQUICK ANCHORDec 5, 2019MalfunctionMW5091503
- THREADED CLEAR CANNULA WITH OBTURATORNov 20, 2019InjuryMW5091207
Recalls
88 on file
- Open, ClassifiedMar 11, 2025
Device is missing the pin in the graft loader component.
View FDA record ↗ - Open, ClassifiedMar 11, 2025
Device is missing the pin in the graft loader component.
View FDA record ↗ - Open, ClassifiedJun 2, 2023
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
View FDA record ↗ - Open, ClassifiedJun 2, 2023
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
View FDA record ↗ - Open, ClassifiedJun 2, 2023
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
View FDA record ↗ - Open, ClassifiedJun 2, 2023
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
View FDA record ↗ - Open, ClassifiedJun 2, 2023
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
View FDA record ↗ - TerminatedJan 15, 2016
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
View FDA record ↗ - TerminatedJan 15, 2016
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
View FDA record ↗ - TerminatedJan 15, 2016
Product is incorrectly labeled. The blade configuration in the affected lots does not match the description on the label.
View FDA record ↗
Compliance history
Matched by FEI 1221934.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.