Recall Z-1314-2025 ยท LXH Orthopedic Manual Surgical Instrument
DePuy Mitek, Inc., a Johnson & Johnson Co.
COR Disposable Kit, 8 mm. Cartilage Transplant System.
| Date | Mar 11, 2025 (initiated Feb 24, 2025) |
| Status | Open, Classified |
| Reason | Device is missing the pin in the graft loader component. |
| Root cause | Employee error |
| Action | 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 inf |
| Quantity | US: 131 units; OUS: 312 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.