—#109890

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.

FDA product code: GAC — Rasp, Surgical, General & Plastic Surgery
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: 510K exempt Catalog Number 1020-1400 Lot Code P5E93

Why it was recalled

Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Drive, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2011-12-29
Posted by FDA: 2012-06-15
Terminated: 2013-06-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109890. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.