Z-1314-2025 Class II Ongoing
FDA device recall Z-1314-2025 was initiated by DePuy Mitek, Inc., A Johnson & Johnson Co. on Feb 24, 2025 and is designated Class II. Reason for recall: Device is missing the pin in the graft loader component. The recall status is ongoing. Affected quantity: US: 131 units; OUS: 312 units.
Recall details
- Product Type
- Devices
- Report Date
- Mar 19, 2025
- Initiation Date
- Feb 24, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 131 units; OUS: 312 units
Product description
COR Disposable Kit, 8 mm. Cartilage Transplant System.
Reason for recall
Device is missing the pin in the graft loader component.
Distribution pattern
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.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1314-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026