BEUDAMED
    FDA Enforcement Class II Terminated

    Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products

    Recall: Z-2044-2014 · Reported July 23, 2014

    Enforcement

    Recall Number
    Z-2044-2014
    Event ID
    68570
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MTI Precision Products LLC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 23, 2014
    Initiation Date
    May 7, 2012
    Classification Date
    July 12, 2014
    Termination Date
    March 12, 2015
    Address
    730 Airport Rd Suite 1, N/A, Lakewood, NJ, 08701-5994, United States

    Description

    Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products

    Reason

    Sharp edge on the body/housing of the Lynx TM20 TorqueMaster Low Speed Handpiece.

    Code Info

    P/N Lynx TM20-4H-01: T41202012, T41202013, T41203001, T41203002, T41203003, T41203010, T41204001 to T41204006 P/N Lynx TM20-4H-03 distributed to end user accounts with serial number T41204001 P/N Lynx TM20-2H-03 distributed to Medidenta private labeled as "Meditorque I 20 K" with serial numbers M21203001 to M21203025. P/N Lynx distirbuted to Medidenta private labeled as "Meditorque I 20 K" with serial numbers M21203026 to M21203055. P/N Lynx TM20-4H-01 distributed to Johnson-Promident with serial numbers T41204001-T41204020 P/N Lynx TM20-2H-01 distirbuted to Johnson-Promident with serial numbers T21204001-T21204020.

    Distribution

    US Nationwide Distribution in the states of CA, FL, IL, KY, MA, MD NJ, NY, and RI.

    Quantity

    134 devices