PlainRecordsFDA · Medical device recall
Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit… and 2 more products
- Date posted by the FDA
- July 13, 2005
- Status
- Terminated
- Filed by
- Warsaw Orthopedic, Inc.
- Reason
- The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
- Distribution pattern
- Nationwide, Australia, Brazil, Canada, Chile, China, Dubai, Hong Kong, India, Korea, Mexico, Netherlands, South Africa and Taiwan.
3 products in this recall
Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit…
- Product
- Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016.
- Codes and lots
- All lots.
- Recall started
- June 20, 2005
- Device type
- Arthroscope
- Root cause (FDA)
- Package design/selection
- What the company told customers
- Consignees were notified, via letter dated June 20, 2005, of the problem and to return all non-expired product.
- Recall number
- Z-0991-05
Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit…
- Product
- Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018.
- Codes and lots
- All lots.
- Recall started
- June 20, 2005
- Device type
- Arthroscope
- Root cause (FDA)
- Package design/selection
- What the company told customers
- Consignees were notified, via letter dated June 20, 2005, of the problem and to return all non-expired product.
- Recall number
- Z-0992-05
Medtronic Sofamor Danek brand METRx System MD Procedure Kit…
- Product
- Medtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030.
- Codes and lots
- All lots.
- Recall started
- June 20, 2005
- Device type
- Arthroscope
- Root cause (FDA)
- Package design/selection
- What the company told customers
- Consignees were notified, via letter dated June 20, 2005, of the problem and to return all non-expired product.
- Recall number
- Z-0993-05
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0991-05, Z-0992-05, Z-0993-05. The agency record governs; check it and the company before acting.