BEUDAMED
    FDA Recall Terminated

    Straumann Dental Implant System, SP Profile Drill, Short, 04.2 mm, RN, L25.0 mm, Stainless steel Ref. Number: 044.084

    Recall: Z-0300-05 · Initiated November 11, 2004

    Recall

    Recall Number
    Z-0300-05
    Event Number
    30482
    Firm
    The Straumann Company
    FEI Number
    1000121052
    Product Code
    NDP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 11, 2004
    Posted
    December 9, 2004
    Terminated
    February 17, 2005
    Address
    1601 Trapelo Road, Waltham, MA, 02451-7333

    Description

    Straumann Dental Implant System, SP Profile Drill, Short, 04.2 mm, RN, L25.0 mm, Stainless steel Ref. Number: 044.084

    Reason

    Outside label incorrectly identifes drill as Regular Neck (RN) instead of Wide Neck (WN)

    Action

    Straumann USA notified users by letter dated 11/11/04 via overnight mail advising users of the label error.

    Distribution

    Nationwide

    Quantity

    85 units