BEUDAMED
    FDA Recall Terminated

    Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660

    Recall: Z-0594-2020 · Initiated October 25, 2019

    Recall

    Recall Number
    Z-0594-2020
    Event Number
    84224
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    October 25, 2019
    Terminated
    April 30, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Biomet Orthopedics Intramedullary Bone Saw Cam Assembly 13MM-Orthopedic manual surgical instrument Item Number: 475660

    Reason

    Possible commingle of 13 MM and 14 MM Intramedullary Bone Saw Cam Assembly -an Intramedullary Bone Saw Cam Assembly was labeled and etched as a 14 MM but measured as a 13 MM cam

    Action

    Zimmer Biomet issued URGENT MEDICAL DEVICE RECALL letter via FedEx and email on 10/25/19. The letter identifies the reason for recall, health risk and action to take: Review this notification and ensure that affected personnel are aware of the contents. 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. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. Questions call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Alternatively, your questions may be emailed to [email protected].

    Distribution

    Distribution to US states of CA, FL, IN, MN, MO, NY, and UT, Australia, and New Zealand

    Quantity

    26 units