Device product
COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System.
Z-1315-2025
Product summary
- Event
- Event 96347
- Status
- Ongoing
- Classification
- Class II
- Quantity
- US: 131 units; OUS: 312 units
- Official record key
device-enforcement:Z-1315-2025
Official wording
Reason: Device is missing the pin in the graft loader component.
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.
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.
Derived failure modes
-
Unknown
Device is missing the pin in the graft loader component.