Innovasis, Inc recalls Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Prod…

Recall date

May 5, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2153-2017

FDA classification

Class II

Brand / firm

Innovasis, Inc

Sold / distributed

US Nationwide Distribution in the states of  CA, UT, ID, TX, OH, and MN.

Why it was recalled

Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.