COR Disposable Kit, 8 mm. Cartilage Transplant System.
This recall is currently active, issued March 11, 2025. It was issued by Depuy Mitek, Inc., A Johnson & Johnson Co..
- Recall Initiated
- February 24, 2025
- Posted
- March 11, 2025
- Recall Number
- Z-1314-2025
- Quantity
- US: 131 units; OUS: 312 units
- Firm Location
- Norwood, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Device is missing the pin in the graft loader component.
Distribution
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.
Lot / Code Info
Model No. 252109 & 252112; GTIN: 10886705012374 & 10886705012404; Lot No. 23C11, 23C12, 23E04, 23F02, 23R03, 24A02, 24B01, 24C17, 24P07, 23C13, 23D03, 23D14, 23F01, 24C15, 24K07 & 24N10.
Root Cause
Employee error
Action Taken
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.