BEUDAMED
    FDA Recall Terminated

    Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810

    Recall: Z-1037-2008 · Initiated January 10, 2008

    Recall

    Recall Number
    Z-1037-2008
    Event Number
    46358
    Firm
    Straumann Usa, Llc
    FEI Number
    1000121052
    Product Code
    EGG
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    January 10, 2008
    Posted
    April 30, 2008
    Terminated
    November 6, 2009
    Address
    60 Minuteman Rd, Andover, MA, 01810-1008

    Description

    Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810

    Reason

    Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diameter) and therefore, will not fit into the NC implant (3.0mm diameter) narrow connection.

    Action

    Consignees were notified by telephone on 1/10/08 followed by an Urgent Device Recall letter on January 10, 2008. The letter instructs users to return any affected product to the firm along with a recall acknowledgement form. For additional information, contact 978-747-2514.

    Distribution

    Nationwide Distribution including states of CA, DE, FL, IL, ME, NY, OH, OR, and TX.

    Quantity

    26 units