BEUDAMED
    FDA Recall Terminated

    Straumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008

    Recall: Z-0278-2008 · Initiated September 28, 2007

    Recall

    Recall Number
    Z-0278-2008
    Event Number
    45420
    Firm
    Straumann USA LLC
    FEI Number
    3004975279
    Product Code
    OAT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 28, 2007
    Posted
    December 4, 2007
    Terminated
    April 16, 2010
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008

    Description

    Straumann Palatal Implant , 4.8 L 4.2 mm, Article Number: 042.336S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008

    Reason

    Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.

    Action

    Straumann USA, LLC sent Urgent Device Recall letters, via FedFx on 9/28/07, requesting the return of all Straumann Palatal Implant, articles 042.335 with lot numbers 1001, FE3776, F4662, F6563, E7083, and article 042.336S lot number 1001.

    Distribution

    Nationwide Distribution - USA including states of AZ, CA, CO, ID, IL, IN, GA, KY, NH , MA, MD, MI, NM, PA, TX, UT, VA, and WA.

    Quantity

    32 units