Recall Z-0435-2008 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Depuy Orthopaedics, Inc.
Depuy TK2 Compression Hip Screw trauma plate, Short Barrel, 135 DEG, 4H-92.6mm, sterile; REF 8315-35-104, DePuy Orthopaedics, Inc., Warsaw, IN 46581
| Date | Jan 24, 2008 (initiated Oct 30, 2007) |
| Status | Terminated |
| Reason | Mis-etched/labeled as to barrel length: the lot with the short barrel was etched and labeled as a standard barrel and the lot with the standard barrel was etched and labeled as a short barrel. |
| Root cause | Process control |
| Action | Consignees were notified via Urgent Information, Recall Notice(letter) dated 10/30/07 to determine whether they have product on hand and to contact their sales representative to return the product. Dear Doctor letters will be issued to implanting physicians as they are identified. |
| Quantity | 4 |
| Distribution | Nationwide including the states of Florida, Massachusetts, Ohio, Pennsylvania, South Carolina, Tennessee and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972629 | DEPUY AE TK2 HIP SCREW SYSTEM Depuy, Inc., Oct 9, 1997 |