BEUDAMED
    FDA Enforcement Class II Terminated

    Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 TLTS0007-20-S19, TLT911-35-S01 TLT911-35-S01.

    Recall: Z-1882-2016 · Reported June 8, 2016

    Enforcement

    Recall Number
    Z-1882-2016
    Event ID
    73948
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Greatbatch Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2016
    Initiation Date
    April 26, 2016
    Classification Date
    June 1, 2016
    Termination Date
    June 7, 2018
    Address
    2300 Berkshire Ln N, N/A, Plymouth, MN, 55441-4575, United States

    Description

    Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 TLTS0007-20-S19, TLT911-35-S01 TLT911-35-S01.

    Reason

    Greatbatch Medical has initiated a global Field Recall for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction For Use (IFU) provided with the device.

    Code Info

    6307760001

    Distribution

    US: IN, MI, TX. OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.

    Quantity

    2