BEUDAMED
    FDA Enforcement Class II Terminated

    RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric Universal Driver is intended for surgical procedures involving driving wire or pins into bone and hard tissue. This includes but is not limited to Dental, ENT (Ear, Nose, Throat), Neuro, and Endoscopic applications. This device can also be used with the Total Performance System (TPSTM).

    Recall: Z-1742-2013 · Reported July 24, 2013

    Enforcement

    Recall Number
    Z-1742-2013
    Event ID
    65456
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Instruments Div. of Stryker Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 24, 2013
    Initiation Date
    July 1, 2013
    Classification Date
    July 16, 2013
    Termination Date
    September 16, 2013
    Address
    4100 E Milham Ave, N/A, Portage, MI, 49002-9704, United States

    Description

    RemB Electric Universal Driver REF 6400-099-000 For use with the CORE and TPS System sRx Only The RemB Electric Universal Driver is intended for use with the Consolidated Operating Room Equipment (CORE TM) System. When used with a variety of accessories, the RemB Electric Universal Driver is intended for surgical procedures involving driving wire or pins into bone and hard tissue. This includes but is not limited to Dental, ENT (Ear, Nose, Throat), Neuro, and Endoscopic applications. This device can also be used with the Total Performance System (TPSTM).

    Reason

    The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100

    Code Info

    0910505713, 1029801073, 1225400823, 1314201603, 1314300713, 1314300723, 1314300733, 1314300743, 1314300753, 1314300763, 1314300773, 1314300783, 1314300793, 1314300803, 1314300813, 1314300823, 1314300833, 1314300843, 1314300853, 1314300863, 1314300873, 1314300883, 1314300893, 1314300903, 1314804033, 1314900053, 1314906453, 1314908193

    Distribution

    Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.

    Quantity

    9