BEUDAMED
    FDA Enforcement Class II Terminated

    EZPass Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.

    Recall: Z-1803-2014 · Reported June 25, 2014

    Enforcement

    Recall Number
    Z-1803-2014
    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 Passer, Sterile single use arthroscopic instrument utilized in conjunction with a nitinol wire to aid in passing suture through soft tissue. Part numbers 904050, 904051, 904052, 904053, 904054, 904055, and 904056.

    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 # 904050 Lots M224900, M175380, M060840,Part ##904051 Lots M224930, M224970, M175390 and M060850,Part # 904052 Lots M298610, M225000, M225010, and M060860; Part #904053 Lots M225030, M225020 and M048380; Part # 904054 Lots M225040, M225050, M175420, M060870; Part # 904055 Lot M060880; and Part # 904056 Lots M225100, M175440, and M060890.

    Distribution

    Nationwide Distribution.

    Quantity

    102