Medtronic Sofamor Danek brand METRx System 16 mm Med… recallZ-0991-05 · Warsaw Orthopedic, Inc. · initiated Jun 20, 2005
Terminated All recalls posted in July 2005
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Warsaw Orthopedic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
FDA root cause category: Package design/selection
What the company is doing
Consignees were notified, via letter dated June 20, 2005, of the problem and to return all non-expired product.
Recall details
- Recall number
- Z-0991-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 20, 2005
- Posted by the FDA
- Jul 13, 2005
- Recalling firm
- Warsaw Orthopedic, Inc.
- Product code
- HRX
- FDA submissions
- K993021
- Distribution
- Nationwide, Australia, Brazil, Canada, Chile, China, Dubai, Hong Kong, India, Korea, Mexico, Netherlands, South Africa and Taiwan.
Product description
Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016.
Code information (models, lots, serial numbers)
All lots.
Other devices under the same FDA submission
3 devices cleared under K993021 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- N/A 9560101Medtronic Sofamor Danek, Inc. · ARTHROSCOPE202 reports
- METRx® System 9560757Medtronic Sofamor Danek, Inc. · ARTHROSCOPE2 reports
- METRx® System 9560702Medtronic Sofamor Danek, Inc. · ARTHROSCOPE1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 32511).
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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