Recall Z-2055-2008 ยท HWT Template
Stryker Howmedica Osteonics Corp.
OmniFit HFx Sell Sheets, Literature Number LHFX-SS rev 1. The device consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.
| Date | Sep 16, 2008 (initiated Mar 9, 2005) |
| Status | Terminated |
| Reason | The OmniFit HFx Templates were produced without a warning statement indicating a potential function of fit issue when using -3mm and -5mm heads or sleeves on certain stems. |
| Root cause | Process control |
| Action | Notification letters and Product Accountability Forms were sent to consignees via Fed-ex on March 9, 2005 with return receipt. An advisory notice was sent to Canada and International distributors on March 9, 2005. For information on this recall, contact Rita Intorrella at 201-831-5825 or Greg Schack at 201-831-5399. |
| Quantity | Sell sheets: 1919, Cutting Edge Advantage Brochure: 810 |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.