Recall Z-0126-2016 ยท HSB Rod, Fixation, Intramedullary And Accessories
Synthes (USA) Products LLC
Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
| Date | Oct 15, 2015 (initiated Sep 21, 2015) |
| Status | Terminated |
| Reason | Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument. |
| Root cause | Device Design |
| Action | DePuy Synthes sent an urgent notice of medical device recall letter dated September 21, 2015, to all affected customers to notify them about the issue, the potential risks, and to provide instructions for return of the completed response form and affected devices. Customers with questions were instructed to call 610-719-5450. |
| Quantity | 793 |
| Distribution | US 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 |