Recall Z-1158-06 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Smith & Nephew Inc
Genesis II, Cruciate Retaining, Oxinium, Femoral component, Size 5 left, Part No. 71420136
| Date | Jun 17, 2006 (initiated Apr 12, 2006) |
| Status | Terminated |
| Reason | Mispackaging-A size 5 femoral component, right, box had a size 5 left component in the box. |
| Root cause | Other |
| Action | All consignees were notified of the potential swap on 4/11/2006 via phone. The firm followed with a recall notice dated 05/18/2006. |
| Quantity | 4 units |
| Distribution | Worldwide-including states of LA, NC, IN, and countries of France, and Turkey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.