BEUDAMED
    FDA Recall Terminated

    Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043

    Recall: Z-0840-06 · Initiated March 30, 2006

    Recall

    Recall Number
    Z-0840-06
    Event Number
    35220
    Firm
    Straumann Manufacturing Inc.
    FEI Number
    1000121052
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 30, 2006
    Posted
    May 4, 2006
    Terminated
    June 14, 2006
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008

    Description

    Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043

    Reason

    The occlusal screw is inserted in the bottom of the healing cap body rather than correctly through the top

    Action

    Straumann USA notified accounts by letter dated 3/30/06 via Federal Express. Accounts are requested to return stock.

    Distribution

    Nationwide. CA, CO, CT, IA, IL, IN, FL, GA, MA , MD, MS, NC, NY, OH, OK, PA, TX, WA

    Quantity

    103 units