Class 2 Device Recall Legend Gold, Gold Touch, and Platinum

• Date Initiated by Firm: November 11, 2002
• Date Posted: January 09, 2003
• Recall Status: Terminated on March 21, 2003
• Recall Number: Z-0419-03
• Recall Event ID: 25019
• 510(K)Number: K020069
• Product Classification: Motor, Drill, Pneumatic - Product Code HBB
• Product: Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)
• Code Information: 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.
• FEI Number: 1625507
• Recalling Firm/ Manufacturer: Medtronics Midas Rex; 4620 North Beach Street; Fort Worth TX 76137
• Manufacturer Reason for Recall: Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: PA100-94 cs, PM100-71ea, PM110-5 ea, PM200-24 ea
• Distribution: Nationwide: CA, OH, FL, PA, GA, AZ, LA, MI, TX, NJ, NM, NC, VA, WA, NE, AL, NY, TN
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.

• 510(K) Database: 510(K)s with Product Code = HBB