Z-2062-2020Class II

Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System -

Name: Z-2062-2020 Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System -
Creator: Innovasis, Inc
Published: 2020-04-07
License: https://open.fda.gov/license/

Innovasis, Inc / initiated 2020-04-07 / Terminated / root cause: manufacturing process

FDA source

Innovasis, Inc began a recall of 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... on 2020-04-07. FDA classified it as Class II and gives the reason as "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"...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2062-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-07
Posted: 2020-05-20
Terminated: 2022-01-26
Recalling firm: Innovasis, Inc
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.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 04/07/202, the firm emailed the "URGENT: ADVISORY NOTICE", to consignees informing them of their plan to correct this issue with a three-step approach: 1) Make the consignee aware of the issue. Further, consignees were asked to notify any necessary case reps and/or surgeon users who may need to understand this distinction in the next week, before the firm issues a temporary fix. 2) The firm is initiating the following "temporary fix": Future orders will include reworked caddies with the words "FIXED" and "VARIABLE" removed. By doing this, the default organization is by color and by laser marking on the parts themselves. Fixed screws can be identified by the color (gold) or the first letters of the Part No. on the screw head (APF). Variable screws can be identified by the green color or by Part No. starting with APV. If/when you receive one of these temporary caddies, please pull the screws out of your current caddies and place them in one of the temporary caddies and return the incorrect caddy. Our Customer Service department will provide return shipping labels as necessary. 3) Another recall letter will follow requesting that consignees swap screws from temporary caddies into the correct caddies, and return temporary caddies. On 04/13/2020, the firm emailed "'URGENT: MEDICAL DEVICE RECALL" notices and Response Forms to consignees. The firm is issuing a "temporary Fix": Future orders will include reworked caddies with the words "FIXED" and "VARIABLE" corrected by way of laser engraving. These caddies will be in a conforming state. Upon receiving one of these reworked caddies, please pull the screws out of your current (non-conforming) caddies and place them in one of the reworked (conforming) caddies and return the original non-conforming caddy. The firm will be ordering new caddies that will then be swapped out with the reworked caddies. The firm requests consignees complete and return Product Removal Forms. Product Removal Forms will indicate ho
Quantity in commerce: 6
Distribution: US Nationwide distribution including in the states of CA, AL, LA.
Product codes and lots: Serial numbers: 2339, 2340, 2346, 2351, 2352, 2354,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2062-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2062-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-20

Product code KWQ

K192049Class IIOryx Cervical Plate SystemInnovasis, Inc. / cleared 2019-11-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)