FDAFDA · Food and drugs·Recall number Z-1816-2012
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.
Published June 27, 2012 · Recall initiated: December 29, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Distributor
- Nationwide Distribution
- Lot
- 510K exempt Catalog Number 1020-1400 Lot Code P5E93
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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