FDA Medical Device Recalls (openFDA)
Medtronics Midas Rex: Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)
- Recall number
- Z-0419-03
- Recalling firm
- Medtronics Midas Rex
- Product
- Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)
- Status
- Terminated
- Initiated
- 2002-11-11
- Posted
- 2003-01-09
- Terminated
- 2003-03-21
- Reason
- Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case.
- Root 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
- 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
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K020069"]
- PMA numbers
- not on file
- Product code
- HBB
- Firm FEI
- 1625507
- Firm city
- Fort Worth
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28