BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty

    Recall: Z-2177-2018 · Reported June 20, 2018

    Enforcement

    Recall Number
    Z-2177-2018
    Event ID
    80185
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2018
    Initiation Date
    May 18, 2018
    Classification Date
    June 12, 2018
    Termination Date
    March 31, 2020
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty

    Reason

    One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.

    Code Info

    Lot 385340 UDI: (01) 00880304005310 (17) 280306 (10) 385340

    Distribution

    US Distribution to the states of : FL, GA, IN, MA, NM, UT, and WI. Foreign distribution to Canada and Mexico

    Quantity

    16