BEUDAMED
    FDA Recall 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 · Initiated October 18, 2019

    Recall

    Recall Number
    Z-0591-2020
    Event Number
    84177
    Firm
    Brasseler USA I Lp
    FEI Number
    3004949275
    Product Code
    GFF
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    October 18, 2019
    Terminated
    December 14, 2020
    Address
    1 Brasseler Blvd, Savannah, GA, 31419-9576

    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.

    Action

    Initial contact to customers was by telephone and visit on 18 October 2019. The firm followed with a letter disseminated by email on 10/25/2019. The firm is seeking return of the affected units and will replace them with correct devices.

    Distribution

    US Nationwide distribution.

    Quantity

    387 units