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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Midas Rex Legend Footed Attachment

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 Class 2 Device Recall Medtronic Midas Rex Legend Footed Attachmentsee related information
Date Initiated by FirmNovember 30, 2009
Date PostedDecember 17, 2009
Recall Status1 Terminated 3 on May 12, 2010
Recall NumberZ-0546-2010
Recall Event ID 53996
510(K)NumberK020069 
Product Classification Motor, drill, pneumatic - Product Code HBB
ProductMedtronic 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.
Code Information Serial Numbers: A3275-03, A7094-01, B1536-06, B1536-07, B3532-02, B8465-09, C3472-08, C7120-02, C7255-01, D1646-02, D1972-01, D1972-04, D2604-01, D2604-04, D4212-05, D5683-03, D6441-01, D6504-05, P00197407, P00204906, P00360920 - P00360924, P00363252 - P00363256, P00364049 - P00364052, P00365059 - P00365061, P00365786 - P00365792, P00365794, P00365799, P00365800, P00368100 - P00368103, P00369724 - P00369726, P00369728, P00372167 - P00372171, T-1035-07, T2648-02, T3188-06 and T5016-02.
FEI Number 1625507
Recalling Firm/
Manufacturer		 Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
4620 N Beach St
Fort Worth TX 76137-3219
For Additional Information Contact
817-831-4181
Manufacturer Reason
for Recall		Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionMedtronic 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 in Commerce64
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = HBB
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