BEUDAMED
    FDA Enforcement Class II Terminated

    Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow

    Recall: Z-1046-2019 · Reported April 3, 2019

    Enforcement

    Recall Number
    Z-1046-2019
    Event ID
    82271
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Avitus Orthopaedics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    April 3, 2019
    Initiation Date
    February 18, 2019
    Classification Date
    March 22, 2019
    Termination Date
    April 22, 2020
    Address
    400 Farmington Ave Ste 2826, N/A, Farmington, CT, 06032-1913, United States

    Description

    Avitus¿ Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus¿ Bone Harvester is intended to harvest cancellous bone and bone marrow

    Reason

    Breach in the sterile barrier pouch may compromise sterility of the device.

    Code Info

    Lot Number/Exp. Date Z2458218A 2018-05-01; Z2458253B 2018-05-01; Z2458379B 2018-10-01; Z2458448B 2019-01-01

    Distribution

    US Nationwide distribution to states of: AZ, CA, CT, FL, MD, MI, NM, OH and PA; and Internationally to: Brazil.

    Quantity

    508 units