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.
FDA Recall Z-0546-2010 · Posted 2009-12-17
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Recalling FirmMedtronic Sofamor Danek Usa, Inc - Dallas Distribution
Recall StatusTerminated
Product CodeHBB
Date Initiated2009-11-30
Date Terminated2010-05-12
Product Quantity64
Reason for Recall
Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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