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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Legend Gold, Gold Touch, and Platinum see related information
Date Initiated by Firm November 11, 2002
Date Posted January 09, 2003
Recall Status1 Terminated 3 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. 
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 2		 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 and Original Applicant = MEDTRONIC MIDAS REX
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