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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 Attachment see related information
Date Initiated by Firm November 30, 2009
Date Posted December 17, 2009
Recall Status1 Terminated 3 on May 12, 2010
Recall Number Z-0546-2010
Recall Event ID 53996
510(K)Number K020069  
Product Classification Motor, drill, pneumatic - Product Code HBB
Product 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.
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.
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
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 in Commerce 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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HBB and Original Applicant = MEDTRONIC MIDAS REX
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