Recall Z-2153-2017 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Innovasis, Inc
Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of the cervical spine. Variable angle screws are included to allow the physician great
| Date | May 23, 2017 (initiated May 5, 2017) |
| Status | Terminated |
| Reason | Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14). |
| Root cause | Error in labeling |
| Action | Distributors are being notified by e-mail, with attached copies of the written letter and forms to be printed, signed and returned to Innovasis on 5/5/17. Additional follow-up may be done via telephone and fax to return products. |
| Quantity | 21 |
| Distribution | US Nationwide Distribution in the states of CA, UT, ID, TX, OH, and MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061147 | OPTERYX ANTERIOR CERVICAL PLATE SYSTEM Innovasis, Inc., Jun 30, 2006 |