Device 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.
Z-2062-2020
Product summary
- Firm
- Innovasis, Inc
- Event
- Event 85575
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6
- Official record key
device-enforcement:Z-2062-2020
Official wording
Reason: 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.
Code information: Serial numbers: 2339, 2340, 2346, 2351, 2352, 2354,
Distribution pattern: US Nationwide distribution including in the states of CA, AL, LA.
Derived failure modes
-
Unknown
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.