PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported May 27, 2020

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.

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 c…

Recall #
Z-2062-2020
Affected scope
6
Initiated
April 7, 2020
Compiled from official public sources by the editorial team.
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Innovasis, Inc recalled Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate Syste… - a moderate-severity action.

Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate Syste… was recalled by Innovasis, Inc in May 27, 2020. Reason: Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy…. Check the official notice for the remedy. Verify recall #Z-2062-2020 with the FDA Devices before acting.

The recall

Innovasis, Inc issued this moderate-severity FDA Devices recall-Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy….

Moderate
severity level
6 units
affected scope
Class II
classification
May 27, 2020
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2062-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-2062-2020) was formally reported on May 27, 2020, with the manufacturer initiating the action on April 7, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Innovasis, Inc is listed as the recalling firm, operating out of Salt Lake City, UT. Federal records list the affected scope as 6.

The documented reason for this recall is: 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" shou… Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of CA, AL, LA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 40,422 medical devices recalls on record

-1,00001,0002,0003,0004,0005,000 20052008201120142017202020232026 1,256

Where this recall sits in the database

Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

6

Related Recalls

6

0 from same agency

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.

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-2062-2020
Date reported May 27, 2020
Date initiated April 7, 2020
Recalling firm Innovasis, Inc
Firm location Salt Lake City, UT
Affected scope 6
Distribution US Nationwide distribution including in the states of CA, AL, LA.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

6 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-2062-2020) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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.. Recalled by Innovasis, Inc. Units affected: 6.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 27, 2020. Severity: Moderate. Recall number: Z-2062-2020.
Where was the recalled product distributed?
Distribution: US Nationwide distribution including in the states of CA, AL, LA..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-2062-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nearby Recalls in This Category

Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.

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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 27, 2020.

  • Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.