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Open, Classified

COR Disposable Kit, 8 mm. Cartilage Transplant System.

FDA Recall Z-1314-2025 · Posted 2025-03-11

Recalling FirmDePuy Mitek, Inc., a Johnson & Johnson Co.
Recall StatusOpen, Classified
Product CodeLXH
Date Initiated2025-02-24
Product QuantityUS: 131 units; OUS: 312 units

Reason for Recall

Device is missing the pin in the graft loader component.

Firm 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 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.

Root Cause

Employee error

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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