BEUDAMED
    FDA Enforcement Class II Terminated

    Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168

    Recall: Z-2813-2020 · Reported August 26, 2020

    Enforcement

    Recall Number
    Z-2813-2020
    Event ID
    86045
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 26, 2020
    Initiation Date
    July 14, 2020
    Classification Date
    August 14, 2020
    Termination Date
    September 7, 2021
    Address
    3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States

    Description

    Smart Stapes Protheses Piston 0.4mm X 5.25 mm- Partial Ossicular Replacement Catalog Number: 70142168

    Reason

    Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below

    Code Info

    Lot number: PR898678

    Distribution

    CA , FL , GA , PA Foreign: New Zealand , Switzerland

    Quantity

    16 units