BEUDAMED
    FDA Enforcement Class II Terminated

    EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.

    Recall: Z-1801-2014 · Reported June 25, 2014

    Enforcement

    Recall Number
    Z-1801-2014
    Event ID
    68216
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 25, 2014
    Initiation Date
    April 15, 2014
    Classification Date
    June 16, 2014
    Termination Date
    July 7, 2015
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    EZPass Suture Retriever, Nitinol, Single Pack, Part number 10007380. Orthopedic Manual Surgical Instrument, Sterile, single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue.

    Reason

    The nitinol wire or monofilament may buckle within the EZPass Suture Passer and become kinked making the wire/monofilament difficult to use.

    Code Info

    Part numbers 110007380 Lot 223570 and 803860

    Distribution

    Nationwide Distribution.

    Quantity

    100 units