Recall Z-0546-2010 ยท HBB Motor, Drill, Pneumatic
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Medtronic Midas Rex Legend Footed Attachment, AF01. Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotomy applications.
| Date | Dec 17, 2009 (initiated Nov 30, 2009) |
| Status | Terminated |
| Reason | Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020069 | MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM Medtronic Midas Rex, Mar 18, 2002 |