Recall Z-0012-06 ยท JDS Nail, Fixation, Bone
EBI, L.P.
EBI Trochanteric 11mm Long Nail.
| Date | Oct 7, 2005 (initiated Jun 24, 2005) |
| Status | Terminated |
| Reason | Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification. |
| Root cause | Other |
| Action | The firm sent out via e-mail notification to their field representatives on 6/27/2005 to identify, remove and return to EBI all affected product from their inventories. One direct customer, Dr. Maylack was sent a recall letter on 7/7/2005. |
| Quantity | 102 nails |
| Distribution | There are 9 sales representatives that are instructed to remove and return the EBI nail from nationwide customers. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050118 | EBI TROCHANTERIC NAIL SYSTEM Ebi, L.P., Feb 16, 2005 |