BEUDAMED
    FDA Recall Terminated

    Tapered Screw-Vent MTX Model TSVTB11

    Recall: Z-0284-2018 · Initiated November 20, 2017

    Recall

    Recall Number
    Z-0284-2018
    Event Number
    78635
    Firm
    Zimmer Dental Inc
    FEI Number
    2023141
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 20, 2017
    Terminated
    February 28, 2024
    Address
    1900 Aston Ave, Carlsbad, CA, 92008-7308

    Description

    Tapered Screw-Vent MTX Model TSVTB11

    Reason

    Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.

    Action

    Recall notification letters will be sent to distributors and clinicians on or about the last week of November 2017. International distributors will be notified via courier or email. Clinicians will be instructed to; 1. Follow any specified patient monitoring instructions, 2. Return Attachment 1 (Acknowledgment of Responsibility) to Zimmer Biomet, 3. Review their inventory and returning any affected product.

    Distribution

    US, Canada, France, Italy, Spain, Germany

    Quantity

    500 units