Z-1315-2025Class II

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

Name: Z-1315-2025 COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2025-02-24
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2025-02-24 / Open, Classified / root cause: manufacturing process

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System on 2025-02-24. FDA classified it as Class II and gives the reason as "Device is missing the pin in the graft loader component". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1315-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-24
Posted: 2025-03-11
Recalling firm: DePuy Mitek, Inc.
Product: COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Device is missing the pin in the graft loader component.
Root cause tag: manufacturing process
FDA root 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1315-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1314-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-11
Z-1315-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-19	2025-03-11

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)