BEUDAMED
    FDA Enforcement Class II Terminated

    XP-CR Tibial Tray - Interlok 73mm Item # 195274

    Recall: Z-2509-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2509-2019
    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 73mm Item # 195274

    Reason

    The locking bar not fully engaging

    Code Info

    Lot Number 553880 590760 663690 553880R 590750 663670 262430 513080 663720 513080R 472990 938180 578980 090230 159280 676320 258090 043920 066220 206850 322110 352860 841550 917740 966760 283230 374810 283240 996010 352850 352850R 429270 851300 383710 041300 585600 076010 469520 578970 599150 600800 600800R 279040 450360 672600 374090 943410 712580 121150 018040 821330 121140 199740 218670 717190 308100 308110 502840 513070 571040 502840R 513070R 571040R

    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

    327 units