BEUDAMED
    FDA Recall Terminated

    ***REF C9944A***"FULL RADIUS RESECTOR"***2.9mm***Qty 6***STERLING***STERILE***Rx Only.*** Made in the USA***Manufacturer: CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***ConMed Linvatec Biomaterials, Ltd.Hermiankatu 6-8L 33720 Tampere, FINLAND.***Lot number # 95987. Soft Tissue resection and removal.

    Recall: Z-0987-2012 · Initiated November 12, 2009

    Recall

    Recall Number
    Z-0987-2012
    Event Number
    59092
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    GFA
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 12, 2009
    Posted
    February 10, 2012
    Terminated
    February 13, 2012
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    ***REF C9944A***"FULL RADIUS RESECTOR"***2.9mm***Qty 6***STERLING***STERILE***Rx Only.*** Made in the USA***Manufacturer: CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***ConMed Linvatec Biomaterials, Ltd.Hermiankatu 6-8L 33720 Tampere, FINLAND.***Lot number # 95987. Soft Tissue resection and removal.

    Reason

    ConMed Linvatec, Largo, FL recalled catalog number, C9944A, lot # 95987, 2.9MM Full Radius Resector Blade in November 2009 because there was a possibility that the device was assembled with an incorrect outer tube.

    Action

    A Linvatec Corporation dba ConMed Linvatec sales representative contacted the affected customers by telephone on November 12, 2009. The customers were also contacted by the Recall Coordinator. The product, problem, and action to be taken by the customers were discussed. Customers with the product in their inventory were instructed to return the product to the firm. Contact the firm at 727-399-5205 for questions regarding this recall.

    Distribution

    Product Distributed in the states of Georgia and New York.

    Quantity

    30 Units