BEUDAMED
    FDA Enforcement Class II Terminated

    RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223

    Recall: Z-1024-2017 · Reported January 25, 2017

    Enforcement

    Recall Number
    Z-1024-2017
    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

    RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223

    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-108323 Lot 761680 UDI (01)00880304651524(17)210713(10)761680 Item XL-108223 Lot 419460 UDI (01)00880304651494(17)210713(10)419460

    Distribution

    USA (nationwide) and Internationally to ARGENTINA

    Quantity

    36