Recall Z-1314-2025— DePuy Mitek, Inc., a Johnson & Johnson Co.
Class II · Ongoing
Class II FDA medical device recall by DePuy Mitek, Inc., a Johnson & Johnson Co., initiated 2025-02-24. FDA's recall record names no specific 510(k) clearance for this event. Product: COR Disposable Kit, 8 mm. Cartilage Transplant System.. Reason: Device is missing the pin in the graft loader component..
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-02-24
- Firm location
- Norwood, MA, United States
Product description
COR Disposable Kit, 8 mm. Cartilage Transplant System.
Reason for recall
Device is missing the pin in the graft loader component.
Data sourced from openFDA. This site is unofficial and independent of the FDA.