BEUDAMED
    FDA Enforcement Class II Terminated

    BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.

    Recall: Z-0591-2020 · Reported December 11, 2019

    Enforcement

    Recall Number
    Z-0591-2020
    Event ID
    84177
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Brasseler USA I Lp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 11, 2019
    Initiation Date
    October 18, 2019
    Classification Date
    December 2, 2019
    Termination Date
    December 14, 2020
    Address
    1 Brasseler Blvd, Savannah, GA, 31419-9576, United States

    Description

    BRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective Length, 86mm - Product Usage: Twist drill intended use: to drill into bone in hip or knee surgeries.

    Reason

    One lot of 3.5 mm twist drills were incorrectly laser etched as 2.5 mm the shaft of the device.

    Code Info

    Lot Number NR1VM

    Distribution

    US Nationwide distribution.

    Quantity

    387 units