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Synthes (USA) Products LLC recalls Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head
Recalled October 21, 2015 · FDA recall Z-0126-2016 · Synthes (USA) Products
Hazard
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. · FDA Class II
Units
793
Sold at
US Nationwide Distribution
Description
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.
Product
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.
Manufacturer(s)
Synthes (USA) Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →