Innovasis, Inc: Medical Device Recall in 2017 - (Recall #: Z-2153-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 5, 2017

Date Posted: May 31, 2017

Recall Number: Z-2153-2017

Event ID: 77206

Reason for Recall:

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

Status: Terminated

Product Quantity: 21

Code Information:

Lot #1601

Distribution Pattern:

US Nationwide Distribution in the states of CA, UT, ID, TX, OH, and MN.

Voluntary or Mandated:

Voluntary: Firm initiated