BEUDAMED
    FDA Recall Terminated

    Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor used in plastic surgery procedures to retract tissue.

    Recall: Z-0415-2009 · Initiated October 24, 2008

    Recall

    Recall Number
    Z-0415-2009
    Event Number
    50149
    Firm
    Biomet Microfixation, Inc.
    FEI Number
    1032347
    Product Code
    FDG
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 24, 2008
    Posted
    November 28, 2008
    Terminated
    September 11, 2009
    Address
    1520 Tradeport Dr, Jacksonville, FL, 32218-2480

    Description

    Fredrick's Converse Retractor #5 F/O, Model Number: 01-0485. A fiber optic retractor used in plastic surgery procedures to retract tissue.

    Reason

    Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08.

    Action

    Consignee was notified by certified mail via an Urgent Medical Device Recall Notice dated 10/24/08, with return receipt. The letter identifies the product and states the issue with the product. The letter required the customer to discontinue use of the item and return it to Biomet Microfixation so that they may rework the instrument. It also asked the customer to notify any hospital personnel responsible for receiving recall notices of this action if the product had been further distributed. The RGA number should be utilized to return the products. The Inventory Reconciliation sheet should be filled out and faxed to 904-741-9425.

    Distribution

    Nationwide Distribution --- including states of Chicago, IL and La Crosse, WI.

    Quantity

    3