BEUDAMED
    FDA Recall Terminated

    ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-0140, DIAMETER 11mm, LENGTH 140mm, 1 EACH, STERILE R, (FOR USE WITH CEMENT ONLY), SINGLE USE ONLY, (Ti6A14V), Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002

    Recall: Z-0492-2010 · Initiated September 22, 2009

    Recall

    Recall Number
    Z-0492-2010
    Event Number
    53538
    Firm
    Wright Medical Technology Inc
    FEI Number
    1043534
    Product Code
    MBH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 22, 2009
    Posted
    December 8, 2009
    Terminated
    December 16, 2010
    Address
    5677 Airline Rd, Arlington, TN, 38002

    Description

    ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-0140, DIAMETER 11mm, LENGTH 140mm, 1 EACH, STERILE R, (FOR USE WITH CEMENT ONLY), SINGLE USE ONLY, (Ti6A14V), Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002

    Reason

    Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy segregation, primary alpha and/or a transformed beta matrix in some of the heat lots. The absence of alloying elements results in an area with less strength. For those instances where the product has been implanted, there is the potential increased risk of failure for these patients.

    Action

    Wright Medical initiated the recall of the product on September 22, 2009 by contacting the distributors by telephone followed with letters addressed to the hospitals and surgeons dated October 9, 2009. At the firm, Customer Service is the contact for return instructions and replacement inventory. This phone number is 800-238-7117. Other questions regarding this matter are directed to 800-874-5630.

    Distribution

    Nationwide, Columbia, Brazil, Portugal, UK, Belgium, Austria, and Greece

    Quantity

    37 units