Z-2153-2017Class II

Opteryx Variable Rescue Screw, Part #CP2214, UDI: +M711CP22140/$$801716012. Packaged in heat-sealed plastic...

Name: Z-2153-2017 Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic...
Creator: Innovasis, Inc
Published: 2017-05-05
License: https://open.fda.gov/license/

Innovasis, Inc / initiated 2017-05-05 / Terminated / root cause: labeling and UDI

FDA source

Innovasis, Inc began a recall of Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior... on 2017-05-05. FDA classified it as Class II and gives the reason as "Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2153-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-05
Posted: 2017-05-23
Terminated: 2017-08-01
Recalling firm: Innovasis, Inc
Product: Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22140/$$801716012*. Packaged in heat-sealed plastic bag. Product Usage: 4.5mm x 14mm Anterior Cervical Plate System Variable Rescue Screw. The Opteryx Cervical Plate System is intended as a temporary fixation device used for correction and stabilization of the cervical spine. Variable angle screws are included to allow the physician greater flexibility when placing the plates and securing it to the vertebrae.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Distributors are being notified by e-mail, with attached copies of the written letter and forms to be printed, signed and returned to Innovasis on 5/5/17. Additional follow-up may be done via telephone and fax to return products.
Quantity in commerce: 21
Distribution: US Nationwide Distribution in the states of CA, UT, ID, TX, OH, and MN.
Product codes and lots: Lot #1601

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2153-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2153-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-23

Product code KWQ

K061147Class IIOpteryx Anterior Cervical Plate SystemInnovasis, Inc. / cleared 2006-06-30

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)