BEUDAMED
    FDA Recall Terminated

    Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.

    Recall: Z-2059-2015 · Initiated March 6, 2009

    Recall

    Recall Number
    Z-2059-2015
    Event Number
    71528
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    MNH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 6, 2009
    Posted
    July 10, 2015
    Terminated
    July 14, 2015
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.

    Reason

    Incorrect thread form on the screw.

    Action

    Consignees were notified with a Product Recall Notice on 03/06/2009 that all screws must be checked to ensure that any discrepant products to be removed from the field.

    Distribution

    Distributed in the states of FL, GA, IL, NY, TX, and WA.

    Quantity

    749 devices