BEUDAMED
    FDA Enforcement Class II Terminated

    Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty

    Recall: Z-0979-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0979-2018
    Event ID
    79385
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 21, 2018
    Initiation Date
    December 8, 2017
    Classification Date
    March 13, 2018
    Termination Date
    September 4, 2018
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty

    Reason

    Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.

    Code Info

    PN: 113633, LN: 421700, UDI# - (01) 00880304462632 (17) 271014 (10) 421700

    Distribution

    US Nationwide in the states of MN, NJ, CA, TX, ND

    Quantity

    12