Device product
AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (10 mm x 24 mm). For orthopedic use in ligament reconstruction.
Z-2422-2018
Product summary
- Event
- Event 80282
- Status
- Terminated
- Classification
- Class II
- Quantity
- 976 units
- Official record key
device-enforcement:Z-2422-2018
Official wording
Reason: Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.
Code information: Item Number (Lot Number): CM-2409 (40731-2, 40743-5, 41049-1, 41237-2, 41536-2, 41737-2, 42219-2), CM-2410 (40731-3, 40743-6, 41049-2, 41237-3, 41536-3, 41737-3, 42219-3).
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Unknown
Potential for AperFix 24 mm implant breaking inside the drilled femoral socket.