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Recall Observatory FDA recall evidence

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

April 07, 2020

Class II

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

    reason.no_named_rule · v1.0.0

    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.