COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.

FDA device recall Z-1315-2025 · posted 2025-03-11 · Open, Classified

Recall details

Recalling firm

DePuy Mitek, Inc., a Johnson & Johnson Co.

Reason for recall

Device is missing the pin in the graft loader component.

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.

Root cause

Employee error

Status

Open, Classified

Product code

LXH

Quantity affected

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,

Date initiated

2025-02-24

Date posted

2025-03-11

Location

Norwood, MA