Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)
This recall has been terminated (originally issued January 9, 2003).
- Company
- Medtronics Midas Rex
- Recall Initiated
- November 11, 2002
- Posted
- January 9, 2003
- Terminated
- March 21, 2003
- Recall Number
- Z-0419-03
- Quantity
- PA100-94 cs, PM100-71ea, PM110-5 ea, PM200-24 ea
- Firm Location
- Fort Worth, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case.
Distribution
Nationwide: CA, OH, FL, PA, GA, AZ, LA, MI, TX, NJ, NM, NC, VA, WA, NE, AL, NY, TN
Lot / Code Info
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.
Root Cause
Other
Action Taken
Recall letter was sent on 11/11/2002 to all consignees requesting that the consignee contact the Medtronic Neurologic Technologies sales representative for replacement.