BEUDAMED
    FDA Enforcement Class II Terminated

    XP- CR Tibial Tray- Interlok 59mm Item # 195268

    Recall: Z-2503-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2503-2019
    Event ID
    83594
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2019
    Initiation Date
    August 15, 2019
    Classification Date
    September 12, 2019
    Termination Date
    April 16, 2021
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    XP- CR Tibial Tray- Interlok 59mm Item # 195268

    Reason

    The locking bar not fully engaging

    Code Info

    Lot Number 004960 262370 130580 004970 130630 130550 130610 130560 130570 004950 130590 279210

    Distribution

    State NY IN OH MI GA SC FL MO WI MN ND SD NE NJ PA MD IL IA CA VA NC DC WV AR AL MS AL MI WA OR ID LA FL KS TN MA KY OK TX TX CT AZ NV NM MT WY CO UT DC WY Country: KOREA CHINA CANADA AUSTRALIA JAPAN EMEA SWEDEN ITALY

    Quantity

    45 units