Recall Z-1816-2012 · GAC Rasp, Surgical, General & Plastic Surgery

Stryker Howmedica Osteonics Corp.

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

Date	Jun 15, 2012 (initiated Dec 29, 2011)
Status	Terminated
Reason	Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.
Root cause	Device Design
Action	Stryker Orthopaedics sent an email notification to all consignees on December 29, 2011, which was followed by an Urgent Product Recall letter dated January 4, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete the attached Product Recall Acknowledgement Form and fax back to 201-831-8089 within 5 days. Customers were also asked to contact the hospitals in their territory that have the affected product to arrange return of the product. Customers were instructed to return the affected product to the attention o
Quantity	41 units
Distribution	Nationwide Distribution
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.