BEUDAMED
    FDA Enforcement Class II Terminated

    ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331

    Recall: Z-0517-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0517-2020
    Event ID
    84124
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    December 4, 2019
    Initiation Date
    August 6, 2019
    Classification Date
    November 22, 2019
    Termination Date
    August 24, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331

    Reason

    The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331.

    Code Info

    Model Number: 11032331 Lots: 784060, 662870

    Distribution

    CA, IN, MN, NJ, NY, AR, LA, OH, KY, TX, CO (US) CA, CN, NL (International)

    Quantity

    73