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Medtronic Midas Rex Classic, GS and Legend dissecting tools… recallZ-1574-05 · Power Surgical Solutions · initiated Sep 1, 2005

Terminated All recalls posted in September 2005

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Power Surgical Solutions or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential compromise of sterile packaging for disposable dissecting tools.

FDA root cause category: Other

What the company is doing

Firm notified consignees by letter on 9/1/2005.

Recall details

Recall number
Z-1574-05
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 1, 2005
Posted by the FDA
Sep 21, 2005
Recalling firm
Power Surgical Solutions
Quantity
3,522,710 units
Product code
GET
FDA submissions
K020069, K900388, K952463, K953432, K953433
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 description

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 (models, lots, serial numbers)

All lot numbers.

Other devices under the same FDA submission

109 devices cleared under K020069, K900388, K952463, K953432, K953433 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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