BEUDAMED
    FDA Enforcement Class II Terminated

    Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.

    Recall: Z-2085-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2085-2016
    Event ID
    74275
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 6, 2016
    Initiation Date
    May 13, 2016
    Classification Date
    June 28, 2016
    Termination Date
    June 13, 2017
    Address
    4620 N Beach St, Haltom City, TX, 76137-3219, United States

    Description

    Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.

    Reason

    Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.

    Code Info

    All Serial Numbers.

    Distribution

    Worldwide Distribution-Including the states of AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, MA, MD, NC, NH, NY, SC, TN, TX, and UT.

    Quantity

    368 devices