Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Oryx Cervical Screw Caddy Recalled by Innovasis, Inc Due to Cervical screw caddies have incorrect text markings for...

Date: April 7, 2020
Company: Innovasis, Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Innovasis, Inc directly.

Affected Products

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.

Quantity: 6

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Innovasis, Inc

Innovasis, Inc has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report