Class 2 Device Recall COR" Disposable Kit

• Date Initiated by Firm: February 24, 2025
• Date Posted: March 11, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1314-2025
• Recall Event ID: 96347
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: COR Disposable Kit, 8 mm. Cartilage Transplant System.
• Code Information: 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.
• Recalling Firm/ Manufacturer: DePuy Mitek, Inc., a Johnson & Johnson Co.; 249 Vanderbilt Ave; Norwood MA 02062-5033
• For Additional Information Contact: Mona Rehmatullah; 561-494-3036
• Manufacturer Reason for Recall: Device is missing the pin in the graft loader component.
• FDA Determined 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 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.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.