Device product
InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.
Z-1501-2021
Product summary
- Event
- Event 87665
- Status
- Terminated
- Classification
- Class II
- Quantity
- 123 units
- Official record key
device-enforcement:Z-1501-2021
Official wording
Reason: Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
Code information: Lot Number: 168B29619B UDI: 00817701020875
Distribution pattern: AL, AK, CA, IA,IL, IN, KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA
Derived failure modes
-
Unknown
Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended