Recall Z-0369-2014 ยท HSB Rod, Fixation, Intramedullary And Accessories
Synthes USA HQ, Inc.
Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fr
| Date | Nov 20, 2013 (initiated Oct 3, 2013) |
| Status | Terminated |
| Reason | A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed. |
| Root cause | Process control |
| Action | Synthes sent a Field Safety Notice dated October 3, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the options provided in the Field Safety Notice to clarify and mitigate the potential risk. Customers were asked to prepare a list of the affected part and lot numbers and contact the Complaint Unit at 610-719-5596 to receive a Return Authorization Number. Complete and return the Verification Form with the product and Return Authorization number. Customers were also asked to fo |
| Quantity | 350195 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070294 | SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES Synthes (Usa), Mar 1, 2007 |