BEUDAMED
    FDA Recall Terminated

    CONCEPT GRAFIX TENDON STRIPPER. REF TS8850. 7.0MM, QTY 1. Rx Only, Non-Sterile, Made In USA.

    Recall: Z-2585-2010 · Initiated January 29, 2010

    Recall

    Recall Number
    Z-2585-2010
    Event Number
    54561
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    FZW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 29, 2010
    Posted
    September 28, 2010
    Terminated
    January 12, 2011
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    CONCEPT GRAFIX TENDON STRIPPER. REF TS8850. 7.0MM, QTY 1. Rx Only, Non-Sterile, Made In USA.

    Reason

    There is a possibility that the device may exhibit Hydrogen Embrittlement in the material and are subject to potential breakage.

    Action

    Recall Notification Letters were sent to customers on January 29, 2010. Customers were requested to complete and return a Customer Response Form indicating the number of products available for return and number distributed. Each distributor was asked to notifiy their customers if the product was further distributed.

    Distribution

    Distributed throughout U.S. and Internationally to Arab Emirates, Belgium, Canada, China, Columbia, Cyprus, Germany, Denmark, Egypt, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, Republic of Korea, Lithuania, Morocco, Malaysia, Poland, Portugal, Saudi Arabia, El Salvador, Thailand, Taiwan and Viet Nam. Domestic Distribution to CA, FL, GA, IL, IN, KS, MI, MT, NY, OH, PA, TX, and WA.

    Quantity

    149