BEUDAMED
    FDA Enforcement Class II Terminated

    XP-CR Tibial Tray - Interlok 83 mm Item # 195277

    Recall: Z-2512-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2512-2019
    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 83 mm Item # 195277

    Reason

    The locking bar not fully engaging

    Code Info

    Lot Number 141540 513160 571080 262460 938230 938260 966800 996040 066250 283280 663860 851390 663860R 090260 279290 376610 851380 663890 206880 374840 429310 723100 434300 469560 469560R 162000 258130 043950 320350 320330 076100 279070 600830 672690 599180 374130 576070 952400 450390 712610 717220 943430 141520 279280 376570 376590 513140

    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

    180 units