Recall Z-0290-2008 ยท HWR Driver, Prosthesis
Wright Medical Technology Inc
Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002
| Date | Nov 27, 2007 (initiated Oct 4, 2007) |
| Status | Terminated |
| Reason | Breakage: breaking of the connecting foot that is on the distal surface of the instrument |
| Root cause | Device Design |
| Action | The firm notified their distributors of the recall on October 4, 2007, with an Urgent Medical Device Recall letter explaining the problem and requesting return of the product from their inventory and from their consignees. The hospitals were notified of the recall on October 4, 2007 using the same Urgent Device Recall Letter. |
| Quantity | 66 units |
| Distribution | Worldwide-USA and Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.