BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2153-2017 · Reported May 31, 2017

    Enforcement

    Recall Number
    Z-2153-2017
    Event ID
    77206
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Innovasis, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 31, 2017
    Initiation Date
    May 5, 2017
    Classification Date
    May 23, 2017
    Termination Date
    August 1, 2017
    Address
    614 E 3900 S, Salt Lake City, UT, 84107-1902, United States

    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.

    Reason

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

    Code Info

    Lot #1601

    Distribution

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

    Quantity

    21