PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 31, 2017 Initiated: May 5, 2017 #Z-2153-2017

Product Description

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.

Reason for Recall

Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).

Details

Recalling Firm
Innovasis, Inc
Units Affected
21
Distribution
US Nationwide Distribution in the states of  CA, UT, ID, TX, OH, and MN.
Location
Salt Lake City, UT

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Innovasis, Inc. Units affected: 21.
Why was this product recalled? ▼
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 31, 2017. Severity: Moderate. Recall number: Z-2153-2017.

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