Lower riskMedical device recall · FDA · Published April 7, 2020
Innovasis Oryx Cervical Screw Caddy Model BTA-172: Incorrect Labeling Risk
Innovasis recalls Oryx Cervical Screw Caddy Model BTA-172 due to incorrect labeling of fixed and variable rescue screws, which could cause improper installation and interference with cover screws.
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.
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Contact the company
📍Recalling firmInnovasis, Inc614 E 3900 S · Salt Lake City, UT 84107-1902
✎ GovInfoNow plain-language explainer
Innovasis is recalling Oryx Cervical Screw Caddy Model BTA-172 because the labels for fixed and variable rescue screws are swapped. If users install the wrong screw type, it may not sit flush and could back out, interfering with the cover screw and potentially causing complications during spinal surgery. Read more at govinfonow.com/recall/65488-innovasis-oryx-cervical-screw-caddy-model-bta-172-incorrect-labeling.
“Innovasis Oryx Cervical Screw Caddy Model BTA-172: Incorrect Labeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65488-innovasis-oryx-cervical-screw-caddy-model-bta-172-incorrect-labeling. Based on FDA recall #Z-2062-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2062-2020%22&limit=1).
Innovasis, Inc. recalled the Oryx Cervical Screw Caddy (Model BTA-172) on April 7, 2020, after the FDA announced incorrect text markings that could lead to improper screw installation. The Food and Drug Administration issued the recall for the device distributed nationwide.
How to tell if you have it
Brand: Innovasis
Product: Oryx Cervical Screw Caddy
Model Number: BTA-172
Part of: Oryx Cervical Plate System
Serial numbers: 2339, 2340, 2346, 2351, 2352, 2354
Quantity: 6 units
The hazard
The cervical screw caddies feature incorrect text markings for the 4.5mm Fixed and Variable rescue screws, with labels swapped between locations. If a user installs a fixed rescue screw instead of a variable one, the screw head may not be flush or could back out, potentially interfering with the cover screw.
Context
GovInfoNow's records show Innovasis, Inc. has issued three other recalls since January 8, 2018, including an August 14, 2024 recall for interfacing issues and a May 22, 2026 recall regarding undersized anti-torque instruments. Other recent recalls of similar products include the XTANT Medical Xpress Pedicle Screw System (February 18, 2026), the Tornier Perip Screw (December 19, 2025), and the Smith & Nephew BIOSURE HA Screw (November 24, 2025).
How to tell if you have this one
Check for the model number BTA-172 on the Oryx Cervical Screw Caddy. The affected units have serial numbers 2339, 2340, 2346, 2351, 2352, and 2354.
Brand
Innovasis
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Caddy Labels
Verify that the caddy labels correctly identify the screw types as 'Variable' for the location that should hold fixed screws and 'Fixed' for the location that should hold variable screws.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution including in the states of CA, AL, LA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Louisiana.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2062-2020 (April 7, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2062-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.