Recall Z-2243-2013 ยท HTY Pin, Fixation, Smooth
Synthes USA HQ, Inc.
Synthes Cannulated Distal Femoral Nail (Trauma Nail), Part Number 450.851S, 420MM-Sterile. Orthppedic implant device.
| Date | Sep 18, 2013 (initiated Apr 18, 2013) |
| Status | Terminated |
| Reason | Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed. |
| Root cause | Packaging process control |
| Action | A letter dated April 18, 2013 was sent to one consignee who was identified as receiving the affected device. A review of inventory and return of any affected product on hand was requested. Negative responses were also requested. |
| Quantity | 1 |
| Distribution | US distribution to MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970733 | SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM Synthes (Usa), Apr 2, 1997 |