BEUDAMED
    FDA Recall Terminated

    ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

    Recall: Z-2551-2018 · Initiated March 3, 2017

    Recall

    Recall Number
    Z-2551-2018
    Event Number
    79855
    Firm
    Implant Direct Sybron Manufacturing, LLC
    FEI Number
    3001617766
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 3, 2017
    Terminated
    August 6, 2018
    Address
    3050 E Hillcrest Dr, Thousand Oaks, CA, 91362

    Description

    ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.

    Reason

    The main vial label lists the incorrect part number, but the cap label is correct.

    Action

    Recall notifications dated 2/13/2017 were issued to U.S. consignees via UPS overnight on 3/3/2017. Foreign consignees received letters on 3/13/2017 and 3/14/2017.

    Distribution

    Distribution was made to AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, and WA. There was no government/military distribution. Foreign distribution was made to Switzerland, Germany, Lithuania, and Spain.

    Quantity

    124 units