Recall Z-1600-2015 ยท HSB Rod, Fixation, Intramedullary And Accessories
Synthes, Inc.
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
| Date | May 12, 2015 (initiated Apr 9, 2015) |
| Status | Terminated |
| Reason | TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay. |
| Root cause | Process control |
| Action | An urgent Field Safety Notification, dated April 9, 2015, was sent to end users and sales consultants to alert them about the issue and request that they take the following actions: 1) review the instructions listed in this notification; 2) forward this notice to anyone in your facility that needs to be informed; and 3) complete the attached Verification Section (page 4 of this notification) and send a copy of the completed Verification Section by: Fax: (888) 446-5160 or Scan/email: Synthes3152@stericycle.com. |
| Quantity | 8175 |
| Distribution | Distribution US Nationwide and Switzerland. |
| 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 |