BEUDAMED
    FDA Recall Terminated

    Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position

    Recall: Z-1616-2016 · Initiated July 26, 2013

    Recall

    Recall Number
    Z-1616-2016
    Event Number
    73657
    Firm
    Atlas Spine, Inc.
    FEI Number
    3003855635
    Product Code
    MQP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 26, 2013
    Terminated
    July 26, 2019
    Address
    1555 Jupiter Park Dr, Ste 4, Jupiter, FL, 33458-8085

    Description

    Atlas Spine Torque Limiting Handle 6N-m, P/N 70089 Model # ITN-001-000 Used to rotate implant into position

    Reason

    The device was not appropriately set to mitigate the risk of implant fracture upon rotation inside the disc space.

    Action

    Atlas Spine, Inc. informed all consignees of the recall and sub-recall on July 26, 2013, in person, electronically, and/or via email. Firm takes the responsibility of tracking of set return and inventory control of the product. For questions regarding this recall call 561-354-1108, ext 102.

    Distribution

    Nationwide Distribution to FL, MO, and WV.

    Quantity

    16