Recall Z-0604-2018 ยท HSB Rod, Fixation, Intramedullary And Accessories
Synthes (USA) Products LLC
11MM/130 Degree Titanium Trochanteric Fixation Nail 380MM/Right, Sterile
| Date | Jul 21, 2017 |
| Status | Terminated |
| Reason | The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot. |
| Root cause | Employee error |
| Action | The company issued a recall letter on 7/21/2017 asking customers to quarantine affected product and arrange for it to be returned. |
| Quantity | 4 units |
| Distribution | TX, GA, PA, UT and Canada |
| 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 |