FDA Medical devices recall ·
COR Disposable Kit, 8 mm recall
- Recall number
- Z-1314-2025
- Date
- (initiated February 24, 2025)
- Company / brand
- DePuy Mitek, Inc., a Johnson & Johnson Co.
249 Vanderbilt Ave, Norwood, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- US: 131 units; OUS: 312 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
COR Disposable Kit, 8 mm. Cartilage Transplant System.
Why was it recalled?
Device is missing the pin in the graft loader component.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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.
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1314-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.