Recall Z-0921-2013 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Genesys Orthopedic Systems, LLC
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.
| Date | Mar 8, 2013 (initiated Feb 20, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Employee error |
| 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. |
| Quantity | 9 cervical screws |
| Distribution | USA Nationwide Distribution including the states of: CA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111132 | GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM Genesys Spine, Dec 9, 2011 |