Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of the cervical spine. Variable angle screws are included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae.
Recall
- Recall Number
- Z-2153-2017
- Event Number
- 77206
- Firm
- Innovasis, Inc
- FEI Number
- 3004719693
- Product Code
- KWQ
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- May 5, 2017
- Posted
- May 23, 2017
- Terminated
- August 1, 2017
- Address
- 614 E 3900 S, Salt Lake City, UT, 84107-1902
Description
Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$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 greater flexibility when placing the plates and securing it to the vertebrae.
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
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.
US Nationwide Distribution in the states of CA, UT, ID, TX, OH, and MN.
21