Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Opteryx Variable Rescue Screw Recalled by Innovasis, Inc Due to Opteryx Variable Rescue Screws are engraved with incorrect...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Innovasis, Inc directly.
Affected Products
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.
Quantity: 21
Why Was This Recalled?
Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Innovasis, Inc
Innovasis, Inc has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report