Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general s
FDA device recall Z-0546-2010 · posted 2009-12-17 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
- Reason for recall
- Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use.
- Action taken
- Medtronic issued an "Urgent: Medical Device Recall" letter dated November 30, 2009. Consignees were notified of the issued and asked to quarantine any affected product and return affected product to the firm for replacement. For further information, contact Medtronic Powered Surgical Solutions Customer Service at 1-800-433-7080 or 1-817-788-6400.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- HBB
- Quantity affected
- 64
- Distribution
- Worldwide Distribution -- Including the United States (DC, TN, NC, KY, AL, FL, NJ, OH, MI, IN, NY, WA, CA, NV, NM, IA, MO, NE and UT), Great Britain, Brazil, Turkey, Singapore and the Netherlands.
- Date initiated
- 2009-11-30
- Date posted
- 2009-12-17
- Date terminated
- 2010-05-12
- 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 |