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Terminated

Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)

FDA Recall Z-0419-03 · Posted 2003-01-09

Recalling FirmMedtronics Midas Rex
Recall StatusTerminated
Product CodeHBB
Date Initiated2002-11-11
Date Terminated2003-03-21
Product QuantityPA100-94 cs, PM100-71ea, PM110-5 ea, PM200-24 ea

Reason for Recall

Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide: CA, OH, FL, PA, GA, AZ, LA, MI, TX, NJ, NM, NC, VA, WA, NE, AL, NY, TN

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020069MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEMMedtronic Midas Rex · 2002-03-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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