Synthes (USA) Products LLC recalls Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head…

Recall date

September 21, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0126-2016

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

US Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.