FDA-Device2012-06-27Class II
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.
Stryker Howmedica Osteonics Corp.
Hazard
Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.
Sold states
Nationwide Distribution
Affected count
41 units
Manufactured in
325 Corporate Drive, N/A, Mahwah, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1816-2012Don't want to check this manually?
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