FDA-Device2017-05-31Class II
Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx¿ Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of the cervical spine. Variable angle screws are included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae.
Innovasis, Inc
Hazard
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
Sold states
US Nationwide Distribution in the states of CA, UT, ID, TX, OH, and MN.
Affected count
21
Manufactured in
614 E 3900 S, Salt Lake City, UT, United States
Products
Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2153-2017Don't want to check this manually?
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