BEUDAMED
    FDA Recall Terminated

    Avitus Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 The Avitus Bone Harvester is intended to harvest cancellous bone and bone marrow

    Recall: Z-1047-2019 · Initiated February 18, 2019

    Recall

    Recall Number
    Z-1047-2019
    Event Number
    82271
    Firm
    Avitus Orthopaedics, Inc.
    FEI Number
    3011504993
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    February 18, 2019
    Terminated
    April 22, 2020
    Address
    400 Farmington Ave, Ste 2826, Farmington, CT, 06032-1913

    Description

    Avitus Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 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.

    Action

    The firm, Avitus, Initiated phone call to Distributors and Direct Hospital Sales on 2-18-2019, followed up with an Email that included a copy of the letter entitled "Urgent Medical Device Removal" and the response form with instructions. The letter requires the distributor/customer to acknowledge receipt of the letter, assess stock for potentially nonconforming lots, return potentially non-conforming product to Avitus, and to report any adverse event associated with potentially nonconforming material to Avitus. Complete and return the REMOVAL RETURN RESPONSE FORM via EMAIL TO [email protected] within 10 working days. If you have any questions, contact the Principal Consultant, MRC|X at 901-299-9390 or email: [email protected].

    Distribution

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

    Quantity

    207 units