DePuy Mitek, Inc., a Johnson & Johnson Co.: Device Recall
Recall #Z-1315-2025 · 02/24/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1315-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Status
- Ongoing
- Date Initiated
- 02/24/2025
- Location
- Norwood, MA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 131 units; OUS: 312 units
Reason for Recall
Device is missing the pin in the graft loader component.
Product Description
COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
Distribution Pattern
Domestic: Nationwide Distribution; Foreign: Austria, Belgium, Brazil, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Spain, Finland, France, French Guyana, Greece, Israel, India, Italy, Japan, South Korea, Luxemburg, Mexico, Netherlands, Poland, Portugal & Singapore.
Other Recalls by DePuy Mitek, Inc., a Johnson & Johnson Co.
- Class II: Risk 02/24/2025
View all recalls by DePuy Mitek, Inc., a Johnson & Johnson Co. →
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.