BEUDAMED
    FDA Recall Terminated

    Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.

    Recall: Z-1171-2014 · Initiated July 22, 2013

    Recall

    Recall Number
    Z-1171-2014
    Event Number
    67183
    Firm
    Biomet 3i, LLC
    FEI Number
    1038806
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    July 22, 2013
    Posted
    March 12, 2014
    Terminated
    April 21, 2015
    Address
    4555 Riverside Dr, Palm Beach Gardens, FL, 33410-4200

    Description

    Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing.

    Reason

    During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required.

    Action

    Biomet 3i sent an Urgent Medical Device Field Correction Notice dated July 2013 to all affected customer via email, facsimile, or postal mail. The letter identifed the affected product, problem and actions to be taken. Customers were instructed to complete the attached response form and fax to 561-514-6316. For questions contact Biomet 3i customer service at 1-800-342-5454.

    Distribution

    Worldwide Distribution - USA Nationwide in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, including Hawaii and Puerto Rico and the countries of : Argentina, Austria, Canada, China, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Hungary, Israel, Japan, Korea, Mexico, Poland, Portugal, Paraguay, Sweden, Singapore, Taiwan, and Uruguay.

    Quantity

    181