Data Foundry

Medical device recalls 2020

Oryx Cervical Screw Caddy — Class II medical device recall Z-2062-2020

Terminated recall by Innovasis, Inc, reported 2020-05-27, distributed nationwide. Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy

Recall numberZ-2062-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmInnovasis, Inc, Salt Lake City, UT, United States
Recall initiated2020-04-07
Classified2020-05-20
Reported by FDA2020-05-27
Terminated2022-01-26
DistributedNationwide (US)
Quantity6
Reason classeslabeling
Serial numbers2339, 2340, 2346, 2351, 2352, 2354
Model numbersBTA-172

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2062-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.