Z-2062-2020 Class II Terminated
FDA device recall Z-2062-2020 was initiated by Innovasis, Inc on April 7, 2020 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated January 26, 2022). Affected quantity: 6.
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- April 7, 2020
- Termination Date
- January 26, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution including in the states of CA, AL, LA.
Code Information
Serial numbers: 2339, 2340, 2346, 2351, 2352, 2354,