BEUDAMED
    FDA Recall 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 · Initiated December 19, 2019

    Recall

    Recall Number
    Z-0871-2020
    Event Number
    84598
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 19, 2019
    Terminated
    August 11, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    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

    Action

    Zimmer Biomet issued letter via email and FedEx on 12/17/19 stating reason for recall, health risk and action to take: Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. Questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.

    Distribution

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

    Quantity

    67 units