medical Class II Updated 2020-05-27

Innovasis, Inc recalls Oryx Cervical Screw Caddy, Model Number BTA-172, as part of

Recalled Product

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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial numbers: 2339, 2340, 2346, 2351, 2352, 2354,
View official government recall

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