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.

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.

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.