BEUDAMED
    FDA Enforcement Class II 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 · Reported February 7, 2018

    Enforcement

    Recall Number
    Z-0412-2018
    Event ID
    78687
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MicroAire Surgical Instruments, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 7, 2018
    Initiation Date
    May 22, 2017
    Classification Date
    January 26, 2018
    Termination Date
    August 29, 2018
    Address
    3590 Grand Forks Blvd, Charlottesville, VA, 22911-9006, United States

    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)

    Code Info

    LIT 0317305390

    Distribution

    US Distribution.

    Quantity

    42