Events

Recall of Device Recall Legend Gold, Gold Touch, and Platinum

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronics Midas Rex.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    25019
  • Event Risk Class
    Class 2
  • Event Number
    Z-0419-03
  • Event Initiated Date
    2002-11-11
  • Event Date Posted
    2003-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25022
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Motor, Drill, Pneumatic - Product Code HBB
  • Reason
    Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case.
  • Action
    Recall letter was sent on 11/11/2002 to all consignees requesting that the consignee contact the Medtronic Neurologic Technologies sales representative for replacement.

Device

Device Recall Legend Gold, Gold Touch, and Platinum
  • Model / Serial
    LOT NUMBER (S) OR S/N(S):  PA100: T0262, T0367, T0369, T0418, T0466, T0545, T0547, T0657, T0659, T1114, T1784, T1785, T1937. PM100: T0474, T0476-T0479, T0481, T0482, T0486, T0487, T0490, T0491, T0494, T0495, T0498, T0502, T0505, T0506, T0508, T0709, T0710, T0765, T0769, T0776, T0980, T1122, T1124, T1133, T1134, T1137, T1139, T1140, T1142, T1298-T1300, T1303-T1305, T1310-T1312, T1363, T1374, T1377, T1391, T1568, T1574, T1575, T1578-T1580, T1586, T1587, T1590, T1594, T1595, T1597, T1601, T1603, T1684, T1687, T1688, T1695, T1699, T1702, T1708, T1710, T1711, T1722, T1739, T1755. PM110: T1014, T1622, T1624, T1628, T1631. PM200: T0453, T0614, T0615, T0617, T0620, T1149, T1326, T1332, T1430, T1528, T1530-T1532, T1535, T1552, T1556, T1561, T1562, T1564, T1637, T1638, T1640, T1648, T1655.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide: CA, OH, FL, PA, GA, AZ, LA, MI, TX, NJ, NM, NC, VA, WA, NE, AL, NY, TN
  • Product Description
    Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)
  • Manufacturer
    Medtronics Midas Rex

Manufacturer

Medtronics Midas Rex
  • Manufacturer Address
    Medtronics Midas Rex, 4620 North Beach Street, Fort Worth TX 76137
  • Source
    USFDA