Recall Z-0219-2015 ยท HSB Rod, Fixation, Intramedullary And Accessories
Synthes, Inc.
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
| Date | Nov 14, 2014 (initiated Oct 29, 2014) |
| Status | Terminated |
| Reason | The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion. |
| Root cause | Employee error |
| Action | An urgent medical device recall notice, dated October 29, 2014, was sent to end users that identified the product, problem and action to be taken. Customers were instructed to return the device to Synthes along with completing the verification section of the notice. |
| Quantity | 6 |
| Distribution | US Distribution in the states of: AK, FL, OH, OK, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011857 | SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM Synthes (Usa), Sep 12, 2001 |