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Genesys Orthopedic Systems, LLC recalls 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage:
Recalled March 20, 2013 · FDA recall Z-0921-2013 · Genesys Orthopedic Systems
Hazard
Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery. · FDA Class II
Units
9 cervical screws
Sold at
USA Nationwide Distribution including the states of: CA and TX.
Description
Manufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.
Product
3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
Manufacturer(s)
Genesys Orthopedic Systems, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →