FDA-Device2020-05-27Class II
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.
Innovasis, Inc
Hazard
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.
Sold states
US Nationwide distribution including in the states of CA, AL, LA.
Affected count
6
Manufactured in
614 E 3900 S, N/A, Salt Lake City, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2062-2020Don't want to check this manually?
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