BEUDAMED
    FDA Recall Terminated

    Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486

    Recall: Z-0010-2007 · Initiated August 29, 2006

    Recall

    Recall Number
    Z-0010-2007
    Event Number
    36293
    Firm
    Smith & Nephew Inc
    FEI Number
    1020279
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 29, 2006
    Posted
    October 3, 2006
    Terminated
    April 12, 2010
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486

    Reason

    Tibial punches were not manufactured to specification and could break at the tip during use.

    Action

    Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email and telephone follow-up) on 08/29/2006 to request the return of any in stock product.

    Distribution

    Worldwide distribution ----- including USA and countries of Austria, Australia, Belgium, Canada, China, Dubai, France, Germany, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, South Korea, Spain, Turkey, United Kingdom, and Venezuela.

    Quantity

    4800 units