Recall Z-1105-2008 ยท HWA Impactor
Stryker Howmedica Osteonics Corp.
Triathlon Baseplate Impactor Extractor, Orthopedic manual surgical instrument, Catalog Number 6541-4-805, Non-Sterile, Stryker Howmedica Osteonics Corp, Mahwah, NJ 07430
| Date | May 14, 2008 (initiated Feb 23, 2005) |
| Status | Terminated |
| Reason | Insertion/Removal Difficulties: The Baseplate Impactor/Extractor may not assemble/disassemble easily to the baseplate. |
| Root cause | Device Design |
| Action | Consignees were notified via an Important Market Withdrawal Letter sent 2/25/05. The letter instructed users to fax a Product Accountability Form to the recalling firm identifying any affected products and to return them to the firm. The letter informed users that the products will be reworked and returned at a later date. The letter also identified other products that could be used as replacements. For additional information, contact 201-831-5825 or 201-831-5110. |
| Quantity | 293 total units |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.