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.
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
