COR Disposable Kit, 8 mm. Cartilage Transplant System.
Recall
- Recall Number
- Z-1314-2025
- Event Number
- 96347
- Firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- FEI Number
- 1221934
- Product Code
- LXH
- Status
- Open, Classified
- Root Cause
- Employee error
- Initiated
- February 24, 2025
- Posted
- March 11, 2025
- Address
- 249 Vanderbilt Ave, Norwood, MA, 02062-5033
Description
COR Disposable Kit, 8 mm. Cartilage Transplant System.
Device is missing the pin in the graft loader component.
Consignees were sent an URGENT MEDICAL DEVICE RECALL (REMOVAL) notification dated 2/20/25. The notification instructs consignees to examine their inventory and quarantine any affected devices. Recalled product is not to be used. Once affected devices have been quarantined, consignees are to contact their DePuy Synthes Sales Consultant to coordinate their return. Consignees are to complete and return the provided Business Response Form to the provided email address within three business days of receipt. The recall notification should be shared with those in your organization that need to be informed and forwarded to facilities to which product was further distributed. The recall notification should also be posted in a visible area for awareness. Consignees with any questions are to contact their DePuy Synthes Sales Consultant.
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.
US: 131 units; OUS: 312 units