BEUDAMED
    FDA Enforcement Class II Terminated

    ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument

    Recall: Z-0871-2020 · Reported February 5, 2020

    Enforcement

    Recall Number
    Z-0871-2020
    Event ID
    84598
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 5, 2020
    Initiation Date
    December 19, 2019
    Classification Date
    January 28, 2020
    Termination Date
    August 11, 2020
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument

    Reason

    Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach

    Code Info

    Lot Numbers: 827310, 711160, 203240

    Distribution

    US Nationwide and Foreign: countries of Canada, CHINA, NETHERLANDS

    Quantity

    67 units