BEUDAMED
    FDA Enforcement Class II Terminated

    Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152

    Recall: Z-1025-2017 · Reported January 25, 2017

    Enforcement

    Recall Number
    Z-1025-2017
    Event ID
    75970
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 25, 2017
    Initiation Date
    December 19, 2016
    Classification Date
    January 13, 2017
    Termination Date
    September 19, 2017
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152

    Reason

    Product complaints indicated that the part and lot numbers on the packaging differed from the physical product inside the packaging. Risk of delay in surgery.

    Code Info

    Item XL-200152 Lot 339260 UDI (01)00880304491366(17)210713(10)339260

    Distribution

    USA (nationwide) and Internationally to ARGENTINA

    Quantity

    19