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.
FDA Recall Z-0921-2013 · Posted 2013-03-08
Advertisement
Recalling FirmGenesys Orthopedic Systems, LLC
Recall StatusTerminated
Product CodeKWQ
Date Initiated2013-02-20
Date Terminated2013-09-09
Product Quantity9 cervical screws
Reason for Recall
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.
Firm Action
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.
Root Cause
Employee error
Distribution Pattern
USA Nationwide Distribution including the states of: CA and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement