BEUDAMED
    FDA Enforcement Class II Terminated

    Comprehensive Mini Stem, Item No. 113631:

    Recall: Z-0591-2019 · Reported December 19, 2018

    Enforcement

    Recall Number
    Z-0591-2019
    Event ID
    81528
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 19, 2018
    Initiation Date
    October 10, 2018
    Classification Date
    December 7, 2018
    Termination Date
    April 28, 2020
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Comprehensive Mini Stem, Item No. 113631:

    Reason

    Zimmer Biomet is conducting a lot specific medical device recall for two lots of the Orthopedic Salvage System (OSS) and the Comprehensive Shoulder System. The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. The associated risk of this product issue is a potential extension of surgery <30 minutes if a replacement is readily available.

    Code Info

    568150

    Distribution

    Distributed to accounts in IN, MD, MO, MS, and NM.

    Quantity

    3 total