Events

Recall of Device Recall Opteryx Variable Rescue Screw

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Innovasis, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77206
  • Event Risk Class
    Class 2
  • Event Number
    Z-2153-2017
  • Event Initiated Date
    2017-05-05
  • Event Date Posted
    2017-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155431
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Reason
    Opteryx variable rescue screws are engraved with incorrect (larger) size (16 instead of 14).
  • Action
    Distributors are being notified by e-mail, with attached copies of the written letter and forms to be printed, signed and returned to Innovasis on 5/5/17. Additional follow-up may be done via telephone and fax to return products.

Device

Device Recall Opteryx Variable Rescue Screw
  • Model / Serial
    Lot #1601
  • Product Classification
    Orthopedic Devices
  • 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
    Innovasis, Inc

Manufacturer

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