BEUDAMED
    FDA Recall Terminated

    Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants

    Recall: Z-0906-2015 · Initiated October 9, 2014

    Recall

    Recall Number
    Z-0906-2015
    Event Number
    69466
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    October 9, 2014
    Posted
    January 5, 2015
    Terminated
    June 8, 2016
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants

    Reason

    Mislabeled

    Action

    The firm, Exactech, sent an "Urgent Field Safety Notice" letter dated September 30, 2014 to its Consignees/customers by electronic mail on October 9, 2014. The letter described the product, problem and actions to be taken. The customers were instructed to: immediately cease distribution or use of the products; extend information to your accounts that may have this product in their possession; verify whether you have any of the subject femoral components from the specified serial number ranges; complete and return the attached inventory RESPONSE FORM via fax to: 011 61 2 9638 0778 within 48 hrs of receipt of the notice, and contact your Exactech representative to confirm quantities at your location and arrangements for product return and inventory restocking. If you have any questions, contact Manager, Regulatory Affairs at 352-377-1140.

    Distribution

    International Distribution only to countries of: Argentina, Austria, Australia, China, Cyprus, France, Greece, India, Japan, Lebanon, The Netherlands, Spain and Tunisia.

    Quantity

    96