FDA Device recall Z-2062-2020
Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is in…
- FDA Device
- Class II
- terminated
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class II recall of Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is in… by Innovasis, citing 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 c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2062-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-07 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Innovasis |
| Distribution | US |
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.
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.
Identifiers
| code_info | Serial numbers: 2339, 2340, 2346, 2351, 2352, 2354, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2062-2020%22
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