Recall Z-0507-2010 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Stryker Howmedica Osteonics Corp.
OnmiFit HFx Surgical Protocol 127 degree and 132 degree Surgical Protocol; Stryker, 325 Corporate Drive, Mahwah, NJ 07430. Surgical protocols instruct surgeons on proper surgical technique.
| Date | Jan 11, 2010 (initiated Aug 31, 2009) |
| Status | Terminated |
| Reason | Certain surgical protocols do not provide specific instructions for initiating power to the calcar planer prior to engagement with bone. |
| Root cause | Error in labeling |
| Action | "Urgent Product Correction - Surgical Protocol" letters and Product Accountability Forms were sent to consignees via Fed Ex on August 31, 2009 and September 1, 2009 with return receipt. Notification letters described the issue, protocols affected, potential hazard and harm and risk mitigation. Direct questions about the recall by calling 1-201-972-2100 or Customer Service 1 -866-OR-ASSIST (1 -866-672-7747). |
| Quantity | 2,876 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022555 | ACCOLADE C FEMORAL STEMS Howmedica Osteonics Corp., Aug 26, 2002 |