Recall Z-0918-05 ยท HXI Passer, Wire, Orthopedic
EBI, L.P.
Threaded Tip GD Pin 1/8in x 9in Pk 5 Sterile found in Uniflex Profile Tibial Nail P/N 329640.
| Date | Jun 22, 2005 (initiated Mar 16, 2005) |
| Status | Terminated |
| Reason | The wire appears to be soft and the wire bent during insertion. This causes kinks in which the reamer could not pass over the bent/kinked wire. |
| Root cause | Other |
| Action | The firm distributed a recall letter to their EBI Fracture Sales Representatives and their EBI Trauma Distributors on 3/16/2005. |
| Quantity | 152 units |
| Distribution | These devices are distributed nationwide to sales representatives who provide the product directly to the hospital/physician at the time of the surgery. The product was also distributed to Italy and Spain. There are no government accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982953 | TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES Biomet, Inc., Oct 21, 1998 |