BEUDAMED
    FDA Recall Terminated

    Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.

    Recall: Z-1190-2018 · Initiated November 29, 2017

    Recall

    Recall Number
    Z-1190-2018
    Event Number
    78667
    Firm
    Zimmer Dental Inc
    FEI Number
    2023141
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    November 29, 2017
    Posted
    March 5, 2018
    Terminated
    February 8, 2019
    Address
    1900 Aston Ave, Carlsbad, CA, 92008-7308

    Description

    Tapered Screw-Vent MTX, Dental Implant, sterile. Model TSV4B10.

    Reason

    Two lots of the Tapered Screw-Vent Implants, with different outer thread diameters, were inadvertently commingled during the manufacturing process and may be mislabeled.

    Action

    On 11/29/2017, customers were notified via letter. Instructions for distributors include to ensure that affected team members are aware of the recall, immediately locate and quarantine affected devices in inventory, notify consignees if product was distributed, make arrangements to immediately return affected devices, and complete and return the Attachment 1 - Inventory Return Certification Form. Instructions for clinicians include to review the recall notice, examine inventory for affected devices, complete and return the Attachment 2 - Certificate of Acknowledgement, and return all affected devices.

    Distribution

    Worldwide distribution US nationwide, Canada, Chile, Costa Rica, Denmark, France, Hungary, Italy, Japan, Lebanon, Portugal, Serbia, Spain, and Taiwan.

    Quantity

    995 distribution events total