BEUDAMED
    FDA Recall Terminated

    SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone

    Recall: Z-0412-2018 · Initiated May 22, 2017

    Recall

    Recall Number
    Z-0412-2018
    Event Number
    78687
    Firm
    MicroAire Surgical Instruments, LLC
    FEI Number
    2020601
    Product Code
    HTW
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 22, 2017
    Terminated
    August 29, 2018
    Address
    3590 Grand Forks Blvd, Charlottesville, VA, 22911-9006

    Description

    SST TWIST DRILL, STANDARD, 1.6mm Dia. x 127mm, REF 8054-010, STERILE This product line is intended for use in orthopaedic surgery (large and small bone surgeries) to cut bone

    Reason

    One lot was found to contain both the correct twist drill (1.6mm) as well as an incorrect twist drill (2.0mm)

    Action

    MicroAire Surgical Instruments, LLC distributed recall letters on May 22, 2017 MicroAire Surgical Instruments, LLC distributed recall letters to the customers who received the mislabeled twist. Letters will be sent by UPS to expedite the delivery. For further questions, please call (434) 975-8000

    Distribution

    US Distribution.

    Quantity

    42