BEUDAMED
    FDA Enforcement Class II Terminated

    Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30

    Recall: Z-1688-2019 · Reported June 5, 2019

    Enforcement

    Recall Number
    Z-1688-2019
    Event ID
    82759
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 5, 2019
    Initiation Date
    April 26, 2019
    Classification Date
    May 29, 2019
    Termination Date
    April 22, 2021
    Address
    2320 NW 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    Description

    Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30

    Reason

    The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.

    Code Info

    UDI 10885862093202 Serial Numbers: T31634510, T31788559

    Distribution

    OK, VA, FL

    Quantity

    2 units