BEUDAMED
    FDA Recall Terminated

    Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121H QTY 1 3.5 x 10.5 mm Bio-Anchor with Disposable Driver, Preloaded with One #2 Herculine Suture***STERILE ***Linvatec A ConMed Company LINVATEC CORPORATION LARGO, FL 33773 USA***''.

    Recall: Z-1548-05 · Initiated February 22, 2005

    Recall

    Recall Number
    Z-1548-05
    Event Number
    31392
    Firm
    Linvatec Corp.
    FEI Number
    1017294
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 22, 2005
    Posted
    September 21, 2005
    Terminated
    July 7, 2012
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121H QTY 1 3.5 x 10.5 mm Bio-Anchor with Disposable Driver, Preloaded with One #2 Herculine Suture***STERILE ***Linvatec A ConMed Company LINVATEC CORPORATION LARGO, FL 33773 USA***''.

    Reason

    Linvatec has determined there is a possibility the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec. Therefore there is a potential for compromised sterility of the devices.

    Action

    Linvatec will issue the recall notifications to all Linvatec direct consignees and customers by mailings using UPS overnight delivery or equivalent method.

    Distribution

    Product was shipped to consignees and customers (sales representatives, domestic customers, international customers, and international distributors and affiliates).

    Quantity

    289 Units