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Terminated

Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas

FDA Recall Z-0213-05 · Posted 2004-11-20

Recalling FirmPower Surgical Solutions
Recall StatusTerminated
Product CodeHBB
Date Initiated2004-11-03
Date Terminated2005-11-03
Product Quantity12,286 cases of 4 units per case

Reason for Recall

Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).

Firm Action

The firm initiated the recall by letter on November 3, 2004 asking consignees to return unused units.

Root Cause

Other

Distribution Pattern

Product was shipped nationwide and to the following foreign countries: Australia, Canada, Hong Kong, Japan, Netherlands, Columbia, Chile, and Venezuela.

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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