COR recallZ-1315-2025 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated Feb 24, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DePuy Mitek, Inc., a Johnson & Johnson Co. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Device is missing the pin in the graft loader component.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-1315-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 24, 2025
- Posted by the FDA
- Mar 11, 2025
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Quantity
- US: 131 units; OUS: 312 units
- Product code
- LXH
- 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.
Product description
COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- COR 252109Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 recalls0 reports
- COR 252112Medos International Sàrl · ORTHOPEDIC MANUAL SURGICAL INSTRUMENT2 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 96347).
- Z-1314-2025 · Open, ClassifiedCOR Disposable Kit, 8 mm. Cartilage Transplant System.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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