BEUDAMED
    FDA Recall Terminated

    Straumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP Article Number: 021.4512

    Recall: Z-2535-2016 · Initiated July 14, 2016

    Recall

    Recall Number
    Z-2535-2016
    Event Number
    74799
    Firm
    Straumann Manufacturing, Inc.
    FEI Number
    1000121052
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    July 14, 2016
    Terminated
    November 20, 2020
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008

    Description

    Straumann Bone Level Implant, 4.1mm RC, SLA 12mm, TiZr, NTP Article Number: 021.4512

    Reason

    Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration

    Action

    Straumann notified customers via telephone on Thursday, July 14, 2016. Customers with an e-mail address on file were also e-mailed on Friday, July 15, 2016.Straumann notified customers were sent a hard copy letter via UPS on Saturday, July 16, 2016 for delivery on Monday, July 18, 2016. The customers have been notified not to use these implants and to return unused implants to Straumann. The customers that have used the implants have been asked to provide the restorative situation for the implants. Depending on the restorative situation, additional instructions may be necessary to restore the implants.

    Distribution

    Nationwide Distribution.

    Quantity

    33 pieces