Recall Z-0815-2011 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
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;
| Date | Dec 27, 2010 (initiated Nov 1, 2010) |
| Status | Terminated |
| Reason | 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 | Device Design |
| Action | 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. |
| Quantity | 459 units |
| Distribution | Worldwide Distribution: Throughout the US, the countries of Canada and Japan, and the regions of Asia Pacific, Europe, Middle East, Africa, and Latin America. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.