Class 2 Device Recall Stryker Howmedica Osteonics Accolade Offset Rasp Handle

• Date Initiated by Firm: December 29, 2011
• Date Posted: June 15, 2012
• Recall Status: Terminated on June 13, 2013
• Recall Number: Z-1816-2012
• Recall Event ID: 62130
• Product Classification: Rasp, surgical, general & plastic surgery - Product Code GAC
• 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.
• Code Information: 510K exempt Catalog Number 1020-1400 Lot Code P5E93
• FEI Number: 3003070421
• Recalling Firm/ Manufacturer: Stryker Howmedica Osteonics Corp.; 325 Corporate Drive; Mahwah NJ 07430
• For Additional Information Contact: Ms. Collen O'Meara; 201-831-5970
• Manufacturer Reason for Recall: Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.
• FDA Determined 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 of Regulatory Compliance, Stryker Orthopedics, 325 Corporate Drive, Mahwah, New Jersey 07430 with the fluorescent orange PRODUCT REMEDIATION sticker attached indicating the Product Remediation # RA 2011-161. Mark the outer box with the words "Product Recall." For questions customers were instructed to call 201-972-2100. For questions regarding this recall call 201-831-5970.
• Quantity in Commerce: 41 units
• Distribution: Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.