BEUDAMED
    FDA Recall 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 · Initiated May 13, 2016

    Recall

    Recall Number
    Z-2085-2016
    Event Number
    74275
    Firm
    Medtronic Sofamor Danek Usa, Inc Dallas Distribution
    FEI Number
    1625507
    Product Code
    HBE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 13, 2016
    Posted
    June 28, 2016
    Terminated
    June 13, 2017
    Address
    4620 N Beach St, Haltom City, TX, 76137-3219

    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.

    Action

    Recall notification letters were sent to consignees on 05/13/2016.

    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