BEUDAMED
    FDA Recall Terminated

    GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only.

    Recall: Z-2503-2010 · Initiated August 5, 2010

    Recall

    Recall Number
    Z-2503-2010
    Event Number
    56441
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    GFA
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 5, 2010
    Posted
    September 25, 2010
    Terminated
    December 14, 2010
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    GATOR. REF 9263A, 4.2mm STERLING, STERILE Rx Only.

    Reason

    ConMed Linvatec, Largo, FL is recalling ConMed Linvatec 9263A,4.2mm Sterling Blade, Gator Meniscus Cutter, Lot Number 178026 for breech in the sterile barrier.

    Action

    Recall Notifications will be sent to all direct consignees by FedEx, email, Fax, etc. If the account no longer has the product in their possession, they will be asked to respond as such. A Return Material Authorizations Number will be assigned for the returned product as required. Product returned will be placed into quarantine and will be dispositioned in accordance with ConMed Linvatec procedures. 100% of the consignees will be contacted. The reply form is the mechanism to verify notification effectiveness to all consignees. If a reply is not received within approximately 30 business days of the first notification ConMed Linvatec will make two additional contacts by phone and / or email, as necessary, to insure all consignees have received notification and have taken appropriate action. If a reply is not received following the third contact by email or phone, no further contacts will be made to the consignee.

    Distribution

    Products were distributed to ConMed Linvatec consignees, sales representatives and affiliates within the US and Australia. US distribution was to WA, AZ, PA, KS, NM, UT, ID, IL. Products were distributed to ConMed Linvatec Australia.

    Quantity

    174