BEUDAMED
    FDA Recall Terminated

    Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No. 044.088

    Recall: Z-1035-04 · Initiated May 21, 2004

    Recall

    Recall Number
    Z-1035-04
    Event Number
    29271
    Firm
    The Straumann Company
    FEI Number
    1000121052
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 21, 2004
    Posted
    July 20, 2004
    Terminated
    November 16, 2004
    Address
    1601 Trapelo Rd, Waltham, MA, 02451-7333

    Description

    Straumann Dental Implant System SP Profile Drill, Short, 0.35mm, WN, L25.0 mm, stainless steel Article No. 044.088

    Reason

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

    Action

    Straumann notifed conisignees by letter on May 21,2004 via Fed''X overnight advising of the error on the label states WN instead of RN. The user is advised to that the ID on the article is incorrect.

    Distribution

    Nationwide. AL, AZ, CA, DE, FL, IA, MA, MI. MD, NC, NE, NY, NJ, TX

    Quantity

    23 units