Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate ...
FDA Recall #Z-1816-2012 — Class II — December 29, 2011
Product Description
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.
Reason for Recall
Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.
Recalling Firm
Stryker Howmedica Osteonics Corp. — Mahwah, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
41 units
Distribution
Nationwide Distribution
Code Information
510K exempt Catalog Number 1020-1400 Lot Code P5E93
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated