Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc. Powered Surgic
FDA device recall Z-1067-05 · posted 2005-08-03 · Terminated
Recall details
- Recalling firm
- Medtronic Powered Surgical Solutions
- Reason for recall
- Complaints of finger control component breaking off and falling into open surgical wound.
- Action taken
- The firm initiated the recall via letter on July 1, 2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- HBB
- Quantity affected
- 191 motors
- Distribution
- 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
- Date initiated
- 2005-06-29
- Date posted
- 2005-08-03
- Date terminated
- 2007-09-24
- Location
- Fort Worth, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM (K020069) | Medtronic Midas Rex | 2002-03-18 |