BEUDAMED
    FDA Enforcement Class II Terminated

    Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325

    Recall: Z-2269-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2269-2021
    Event ID
    88304
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 18, 2021
    Initiation Date
    June 2, 2021
    Classification Date
    August 12, 2021
    Termination Date
    July 6, 2022
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325

    Reason

    Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

    Code Info

    Lot Numbers/UDI : 880850 (01)00880304480575(17)310412(10)880850

    Distribution

    US Nationwide distribution.

    Quantity

    11 units