FDA-Device2013-03-20Class II
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.
Genesys Orthopedic Systems, LLC
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.
Sold states
USA Nationwide Distribution including the states of: CA and TX.
Affected count
9 cervical screws
Manufactured in
1250 S Capital Of Texas Hwy, Bldg #3, Suite 600, Austin, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0921-2013Don't want to check this manually?
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