Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018.
FDA device recall Z-0992-05 · posted 2005-07-13 · Terminated
Recall details
- Recalling firm
- Warsaw Orthopedic, Inc.
- Reason for recall
- The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design.
- Action taken
- Consignees were notified, via letter dated June 20, 2005, of the problem and to return all non-expired product.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- HRX
- Distribution
- Nationwide, Australia, Brazil, Canada, Chile, China, Dubai, Hong Kong, India, Korea, Mexico, Netherlands, South Africa and Taiwan.
- Date initiated
- 2005-06-20
- Date posted
- 2005-07-13
- Date terminated
- 2006-02-08
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| METRX SYSTEM (K993021) | Surgical Navigation Technologies, Inc. | 1999-11-10 |