Recall Z-1352-2015 ยท HSB Rod, Fixation, Intramedullary And Accessories
Synthes, Inc.
Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
| Date | Mar 30, 2015 (initiated Feb 24, 2015) |
| Status | Terminated |
| Reason | The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments. |
| Root cause | Component design/selection |
| Action | DePuy Synthes sent an Urgent Notice: Medical Device Recall letter, dated March 2, 2015, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to review inventory for the affected parts and following the actions provided in the letter for removal and replacement of these devices. For questions call 610-719-5450. |
| Quantity | 131 |
| Distribution | US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131548 | SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM Synthes (USA) Products, LLC, Feb 28, 2014 |