Recall Z-0452-2014 ยท HSB Rod, Fixation, Intramedullary And Accessories
Synthes USA HQ, Inc.
Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
| Date | Dec 5, 2013 (initiated Jul 30, 2013) |
| Status | Terminated |
| Reason | Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail. |
| Root cause | Nonconforming Material/Component |
| Action | Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affeccted product to obtain a Return Authorization Number, Complete the Verification Section of the letter by checking the appropriate box indicating the affected product has been located. Return the Verification Form with the product to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132. Customers should complete and return |
| Quantity | 17 |
| Distribution | Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT. |
| 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 |