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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Midas Rex Classic, GS and Legend dissecting tools

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  Class 2 Device Recall Medtronic Midas Rex Classic, GS and Legend dissecting tools see related information
Date Initiated by Firm September 01, 2005
Date Posted September 21, 2005
Recall Status1 Terminated 3 on July 25, 2007
Recall Number Z-1574-05
Recall Event ID 33340
510(K)Number K020069  K900388  K953433  K952463  K953432  
Product Classification Motor, Surgical Instrument, Pneumatic Powered - Product Code GET
Product Medtronic Midas Rex Classic, GS and Legend dissecting tools manufactured by Medtronic Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, tX 76137 USA, Rx only, Sterile, Single Use Only.
Code Information All lot numbers.
Recalling Firm/
Manufacturer		 Power Surgical Solutions
4620 N Beach St
Fort Worth TX 76137-3219
Manufacturer Reason
for Recall		 Potential compromise of sterile packaging for disposable dissecting tools.
FDA Determined
Cause 2		 Other
Action Firm notified consignees by letter on 9/1/2005.
Quantity in Commerce 3,522,710 units
Distribution Nationwide and the following foreign countries: Aruba, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Kuwait, Lebanon, Mexico, Netherlands, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Russia, S. Africa, Saudi Arabia, Singapore, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, U.S. Virgin Islands, Uae, United Kingdom, Uruguay, and Venezuela
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 = GET and Original Applicant = MEDTRONIC MIDAS REX
510(K)s with Product Code = GET and Original Applicant = MIDAS REX PNEUMATIC TOOLS, INC.
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