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Z-1574-05

Medtronic Midas Rex Classic, GS and Legend dissecting tools manufactured by Medtronic Inc. Powered Surgical...

Medtronic Powered Surgical Solutions / initiated 2005-09-01 / Terminated / root cause: packaging

Power Surgical Solutions began a recall of Medtronic Midas Rex Classic, GS and Legend dissecting tools manufactured by Medtronic Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, tX... on . The reason FDA records is "Potential compromise of sterile packaging for disposable dissecting tools". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1574-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medtronic Powered Surgical Solutions
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.
Product code
GET Motor, Surgical Instrument, Pneumatic Powered
Reason for recall
Potential compromise of sterile packaging for disposable dissecting tools.
Root cause tag
packaging
FDA root cause
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
Product codes and lots
All lot numbers.