BEUDAMED
    FDA Recall 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 · Initiated April 15, 2014

    Recall

    Recall Number
    Z-1803-2014
    Event Number
    68216
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HWQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 15, 2014
    Posted
    June 16, 2014
    Terminated
    July 7, 2015
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    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.

    Action

    On 2/28/14, customers received a letter stating these devices have been recalled following an investigation which identified that the nitinol wire or monofilament may buckle within the EzPass Suture Passer and become kinked making the wire/monofilament difficult to use. The letter also stated, there is no adverse health outcome expected for the patient and this action requires the immediate location and discontinued use of the product and its return to Biomet.

    Distribution

    Nationwide Distribution.

    Quantity

    102