Recall Z-0375-2016 ยท HSB Rod, Fixation, Intramedullary And Accessories
Synthes (USA) Products LLC
Trochanteric Fixation Nail- Advanced System-11MM/130 DEG TI CANN TFNA 420MM/Right Sterile (The TFN-ADVANCED Proximal Femoral Nailing System) The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures. Intramedullary fixation rod, orthopedic.
| Date | Dec 4, 2015 (initiated Nov 2, 2015) |
| Status | Terminated |
| Reason | TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the handle. Or 2. Cause the bottom of the cannulated connecting screw to tighten against the top of the locking mechanism preventing advancement of the locking mechanism. |
| Root cause | Process control |
| Action | The firm, DePuy Synthes, sent an "URGENT NOTICE:MEDICAL DEVICE FIELD SAFETY NOTIFICATION" letter dated 11/2/2015 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Review the instructions listed in this notification; forward this notice to anyone in your customer's facility that needs to be informed; complete the attached Verification Section and send a copy of the completed Verification Section by: Fax: (866) 629-6186 or Scan/email: Synthes3826@stericycle.com, if the Verification Form is answered on behal |
| Quantity | 5 |
| Distribution | US Distribution to states of: CA, FL, MI and WI. |
| 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 |