BEUDAMED
    FDA Enforcement Class II Terminated

    Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814

    Recall: Z-2235-2019 · Reported August 21, 2019

    Enforcement

    Recall Number
    Z-2235-2019
    Event ID
    83314
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    August 21, 2019
    Initiation Date
    July 2, 2019
    Classification Date
    August 9, 2019
    Termination Date
    September 10, 2021
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814

    Reason

    Cleaning processes potentially being ineffective

    Code Info

    Lot # All lots expiring prior to 06/30/2024 Affected products were distributed between June 2016 and February 2019.

    Distribution

    Distributed to the following states in the USA: AZ, CA, DC, GA, IL, KY, LA, MA, MD, MN, NC, NJ, NM, OH,OK, OR, SC, TX. Distributed to Japan and Netherlands.

    Quantity

    30