Recall Z-0474-2014 ยท HSB Rod, Fixation, Intramedullary And Accessories
Synthes USA HQ, Inc.
Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
| Date | Dec 10, 2013 (initiated Jul 30, 2013) |
| Status | Terminated |
| Reason | Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging. |
| Root cause | Employee error |
| Action | Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 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 take the following actions: Call Syntehs at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section checking the appropriate box indicating affected product has been located. Return the Verfication Form with the product to: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If no affected product found customers were |
| Quantity | 12 |
| Distribution | Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA. |
| 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 |