BEUDAMED
    FDA Enforcement Class III Terminated

    Arthrex Suture Washer

    Recall: Z-2918-2016 · Reported October 12, 2016

    Enforcement

    Recall Number
    Z-2918-2016
    Event ID
    75050
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arthrex, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 12, 2016
    Initiation Date
    August 12, 2016
    Classification Date
    September 30, 2016
    Termination Date
    August 20, 2019
    Address
    1370 Creekside Blvd, N/A, Naples, FL, 34108-1945, United States

    Description

    Arthrex Suture Washer

    Reason

    The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.

    Code Info

    Unique Device Identifier (UDI): 00888867118607; Catalog # AR-7000-18T; Batch #10028617.

    Distribution

    OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.

    Quantity

    45 devices