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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

COR Disposable Kit Recalled Due to Missing Graft Loader Component Pin

Agency Publication Date: March 11, 2025
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Summary

DePuy Mitek, Inc., a Johnson & Johnson company, is recalling approximately 131 units in the U.S. of the COR Disposable Kit Cartilage Transplant System. The recall was issued because the kits are missing a pin in the graft loader component, which is a critical part required for the device to operate properly. These medical kits were distributed directly to hospitals and through medical device distributors nationwide.

Risk

A missing pin in the graft loader can cause the device to fail during surgery, potentially leading to surgical delays or complications during a cartilage transplant. No injuries or incidents have been reported to date.

What You Should Do

  1. The products affected by this recall are the COR Disposable Kit (8 mm) and COR Disposable Kit (8 mm w/ Perpendicularity) Cartilage Transplant Systems manufactured by DePuy Mitek.
  2. Identify the affected products by checking for model numbers 252109 or 252112 and GTINs 10886705012374 or 10886705012404. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately.
  4. Contact the manufacturer, DePuy Mitek, Inc., or your authorized medical device distributor to arrange for the return, replacement, or correction of any affected units.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: COR Disposable Kit, 8 mm. Cartilage Transplant System.
Variants: 8 mm
Model / REF:
252109
252112
Lot Numbers:
23C11
23C12
23E04
23F02
23R03
24A02
24B01
24C17
24P07
23C13
23D03
23D14
23F01
24C15
24K07
24N10
GTIN:
10886705012374
10886705012404

Recall #: Z-1314-2025

Product: COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
Variants: 8 mm w/ Perpendicularity
Model / REF:
252109
252112
Lot Numbers:
23C11
23C12
23E04
23F02
23R03
24A02
24B01
24C17
24P07
23C13
23D03
23D14
23F01
24C15
24K07
24N10
GTIN:
10886705012374
10886705012404

Recall #: Z-1315-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96347
Status: Active
Manufacturer: DePuy Mitek, Inc., a Johnson & Johnson Co.
Sold By: Hospitals; Medical device distributors
Manufactured In: United States
Units Affected: 2 products (US: 131 units; OUS: 312 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.