Device product
Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Single offset rasp handle designed to mate to the Accolade femoral broaches to prepare the femoral canal in a total hip anthroplasty using the Accolade Hip System. The offset rasp handle incorporates an offset angle designed to minimize interference with surrounding soft tissue.
Z-1816-2012
Product summary
- Event
- Event 62130
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41 units
- Official record key
device-enforcement:Z-1816-2012
Official wording
Reason: Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.
Code information: 510K exempt Catalog Number 1020-1400 Lot Code P5E93
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.