BEUDAMED
    FDA Recall Terminated

    Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in boxes containing 100 blades.

    Recall: Z-0862-2009 · Initiated November 17, 2008

    Recall

    Recall Number
    Z-0862-2009
    Event Number
    50499
    Firm
    Miltex, Inc.
    FEI Number
    2518040
    Product Code
    GES
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 17, 2008
    Posted
    February 20, 2009
    Terminated
    February 23, 2009
    Address
    589 Davies Drive, York, PA, 17402

    Description

    Stainless Steel Surgical Blades Part no 4-312B. The product is supplied sterile individually packaged in boxes containing 100 blades.

    Reason

    Blade may break: Over milling of the blade resulted in tip more narrow than specified.

    Action

    An Urgent Medical Device Recall letter dated 11/17/08 with an accompanying fax back form was sent to each customer. Each distributor was instructed to review their inventory, complete the form, and return any affected product. The distributors were also instructed to conduct a sub recall notification.

    Distribution

    Nationwide Distribution and Canada.

    Quantity

    200 boxes