BEUDAMED
    FDA Recall Terminated

    Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT.

    Recall: Z-0499-2010 · Initiated November 6, 2009

    Recall

    Recall Number
    Z-0499-2010
    Event Number
    53813
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 6, 2009
    Posted
    December 10, 2009
    Terminated
    October 8, 2010
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT.

    Reason

    The devices may not meet specifications, which may result in fracturing during tightening of the component.

    Action

    User accounts were notified of the issue by phone on or about 11/6/09. Clinicians were requested to schedule a follow-up appointment and to remove and replace the recalled components for any patients who had this device placed without fracturing during the procedure. Questions are directed to the company at 1-800-854-7019.

    Distribution

    Ohio, Canada and France.

    Quantity

    738