||March 08, 2013
||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.
||Part Number: GCSF37512 and Lot Number: 0243
|Genesys Orthopedic Systems, LLC
1250 S Capital Of Texas Hwy
Bldg #3, Suite 600
Austin, Texas 78746-6446
|For Additional Information Contact
|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.
||Genesys Orthopedic Systems, LLC sent a Recall Notification letter dated February 20, 2013 to all affected customers. The letter identified the affected product, problem and necessary actions to be taken. Customers were instructed to immediately return the affected product to the Genesys Spine office and complete and return the enclosed Response Form as soon as possible. For questions call 512-381-7070.
|Quantity in Commerce
||9 cervical screws
||USA Nationwide Distribution including the states of: CA and TX.