Recall Z-2091-2015 ยท HSB Rod, Fixation, Intramedullary And Accessories
Synthes (USA) Products LLC
Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.
| Date | Jul 16, 2015 (initiated Jun 10, 2015) |
| Status | Terminated |
| Reason | The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017). |
| Root cause | Process control |
| Action | A recall notification letter, dated June 10, 2015, was sent to sales consultants and Synthes distribution sites requesting return of affected devices. |
| Quantity | 32 |
| Distribution | Nationwide Distribution. |
| 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 |