Innovasis, Inc: Medical Device Recall in 2020 - (Recall #: Z-2062-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 7, 2020

Date Posted: May 27, 2020

Recall Number: Z-2062-2020

Event ID: 85575

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.

Status: Terminated

Product Quantity: 6

Code Information:

Serial numbers: 2339, 2340, 2346, 2351, 2352, 2354,

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated