BEUDAMED
    FDA Recall 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 · Initiated April 26, 2016

    Recall

    Recall Number
    Z-1882-2016
    Event Number
    73948
    Firm
    Greatbatch Medical
    FEI Number
    2183787
    Product Code
    HWE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 26, 2016
    Terminated
    June 7, 2018
    Address
    2300 Berkshire Ln N, Plymouth, MN, 55441-4575

    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.

    Action

    Consignees were sent on 4/26/2016 a Greatbatch "Urgent Medical Device Recall" letter dated April 26, 2016. The letter described the product involved in the recall, the reason, and the risk to health. The letter advised consignees to identity and quarantine the product and to complete and return the Filed Recall Response Form. For questions contact your local Greatbatch Medical representative, at 1-763-951-8235, or e-mail [email protected].

    Distribution

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

    Quantity

    2