Device Recall Opteryx Variable Rescue Screw

  • Model / Serial
    Lot #1601
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of  CA, UT, ID, TX, OH, and MN.
  • 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Innovasis, Inc, 614 E 3900 S, Salt Lake City UT 84107-1902
  • Manufacturer Parent Company (2017)
  • Source
    USFDA