Recall Z-2396-2016 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Stryker Howmedica Osteonics Corp.
Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further pr
| Date | Aug 11, 2016 (initiated Jul 1, 2016) |
| Status | Terminated |
| Reason | Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle. |
| Root cause | Device Design |
| Action | Stryker notified Branches/Agencies of the Urgent Medical Device Recall by e-mail on July 1, 2016 and an "Urgent Medical Device Recall Letter and Business Reply Form" was sent to branches, agents and hospital risk management via UPS (with return receipt) on July 5, 2016. The letter identified then affected product, problem and actions to be taken. For questions call (201) 831-6693. |
| Quantity | 241 units |
| Distribution | Worldwide Distribution - US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110290 | EXETER HIP STEM Howmedica Osteonics Corp., Sep 27, 2011 |