# FDA recall Z-2062-2020

> **Innovasis, Inc** · Class II · device recall initiated 2020-04-07.

## 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 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

US Nationwide distribution including in the states of CA, AL, LA.

## Key facts

- **Recall number:** Z-2062-2020
- **Recalling firm:** Innovasis, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-07
- **Report date:** 2020-05-27
- **Termination date:** 2022-01-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salt Lake City, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2062-2020

## Citation

> AI Analytics. FDA recall Z-2062-2020. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-2062-2020. Source: US FDA. Licensed CC0.

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