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Terminated

Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137.

FDA Recall Z-1067-05 · Posted 2005-08-03

Recalling FirmMedtronic Powered Surgical Solutions
Recall StatusTerminated
Product CodeHBB
Date Initiated2005-06-29
Date Terminated2007-09-24
Product Quantity191 motors

Reason for Recall

Complaints of finger control component breaking off and falling into open surgical wound.

Firm Action

The firm initiated the recall via letter on July 1, 2005.

Root Cause

Other

Distribution Pattern

Nationwide. The device was distributed to hospitals and medical facilities in AL, AR, CA, CT, DC, DE, FL, HI, IA, IL, IN, ME, MN, MT, NC, NE, NJ, NM, NY, OH, PA, SC, TN, TX, and VA. Devices were also distributed to the following foreign countries: Japan, Mexico, Netherlands, Canada, 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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