Recall Z-1315-2025— DePuy Mitek, Inc., a Johnson & Johnson Co.

Name: FDA recall Z-1315-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-24

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 w/ Perpendicularity. 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 w/ Perpendicularity. 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.