BEUDAMED
    FDA Recall Terminated

    Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213

    Recall: Z-1041-2020 · Initiated October 7, 2019

    Recall

    Recall Number
    Z-1041-2020
    Event Number
    84801
    Firm
    Implant Direct Sybron Manufacturing LLC
    FEI Number
    3001617766
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    October 7, 2019
    Posted
    February 4, 2020
    Terminated
    April 28, 2021
    Address
    3050 E Hillcrest Dr, Westlake Village, CA, 91362-3171

    Description

    Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213

    Reason

    Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.

    Action

    On 10/07/19, Urgent Medical Device Recall notices were mailed via overnight mail to US customers who were asked to return affected product and to complete and return the acknowledgement form. Consignees in foreign countries were sent Recall notices via overnight mail and/or email on 10/11/2019. Distributors were asked to identify customers that may have received affected product and to inform them of this issue. US Customers with additional questions were encouraged to call Customer Care, Monday through Friday, between 5am-5pm PST, at 1-888-649-6425.

    Distribution

    U.S. Nationwide distribution in the states of: KS, LA, OH, RI, CA, NJ, MA, FL, UT, ID, MO, WY, WI, PA, WA. O.U.S. (Foreign): DE, IT, HU, JP

    Quantity

    72