BEUDAMED
    FDA Enforcement Class II Terminated

    Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation.

    Recall: Z-2062-2020 · Reported May 27, 2020

    Enforcement

    Recall Number
    Z-2062-2020
    Event ID
    85575
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Innovasis, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 27, 2020
    Initiation Date
    April 7, 2020
    Classification Date
    May 20, 2020
    Termination Date
    January 26, 2022
    Address
    614 E 3900 S, N/A, Salt Lake City, UT, 84107-1902, United States

    Description

    Oryx Cervical Screw Caddy, Model Number BTA-172, as part of the Oryx Cervical Plate System - Product Usage: The Cervical Plate System is intended for use in anterior cervical fixation.

    Reason

    Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy location labeled as "Fixed" should be labeled as "Variable" and the caddy location labeled as "Variable" should be labeled as "Fixed. If user installs a fixed rescue screw instead of variable, the screw head may not be flush, it could back out, which could interfere with the cover screw.

    Code Info

    Serial numbers: 2339, 2340, 2346, 2351, 2352, 2354,

    Distribution

    US Nationwide distribution including in the states of CA, AL, LA.

    Quantity

    6