Innovasis, Inc recalls Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervica…

Recall date

April 7, 2020

Source

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

Recall number

Z-2062-2020

FDA classification

Class II

Brand / firm

Innovasis, Inc

Sold / distributed

US Nationwide distribution including in the states of CA, AL, LA.

Why it was recalled

Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy location labeled as "Fixed" should be labeled as "Variable" and the caddy location labeled as "Variable" should be labeled as "Fixed. If user installs a fixed rescue screw instead of variable, the screw head may not be flush, it could back out, which could interfere with the cover screw.

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

What was recalled

Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation.