—#95764

Product

CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, & Specialty Head Center Accolade Broach Handle; Stryker Howmedica Osteonics, Non-sterile Instruments; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430;

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: CuttingEdge Advantage Rasp Handle - Catalog number 1100-1000; All lot codes Straight Rasp Handle - Catalog number 1440-1400; All lot codes Specialty Head Center Accolade Broach Handle - Catalog number I-H088HF00, I-H1389HF00 ; All lot codes

Why it was recalled

The CuttingEdge Advantage Rasp Handle, Straight Rasp Handle, and Specialty Head Center Accolade Broach Handle may fracture in two pieces along the width of the body under the striking plate. This may extend surgical time under anesthesia, cause trauma to the surgeon or patient, or contaminate the surgical site.

Root cause (FDA determination)

Device Design

Action the firm took

Stryker issued a Product Correction Bulletin dated November 2010 to their consignees, alerting surgeons of the need to inspect the instruments before and after each surgical use, and, if a defect is detected, to contact Stryker for return of the product. Stryker can be contacted at 201 831-5288 concerning this issue. In response to their revised strategy, Stryker issued notification letters and product recall acknowledgement forms to their branches and agencies on 2/17/2011 for 2/18/2011 delivery via Fed Ex and to their hospital risk managers on 2/18/2011 for 2/21/2011 delivery via Fed ex.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution: Throughout the US, the countries of Canada and Japan, and the regions of Asia Pacific, Europe, Middle East, Africa, and Latin America.

Timeline

Recall initiated: 2010-11-01
Posted by FDA: 2010-12-27
Terminated: 2014-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95764. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.