medical MODERATE Updated 2017-05-31

Innovasis, Inc recalls Opteryx Variable Rescue Screw, Part #CP2214, UDI: *+M711CP22

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Recalled 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.

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #1601

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
View official government recall