Recall Z-0992-05 ยท HRX Arthroscope
Warsaw Orthopedic, Inc.
Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018.
| Date | Jul 13, 2005 (initiated Jun 20, 2005) |
| Status | Terminated |
| Reason | The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design. |
| Root cause | Package design/selection |
| Action | Consignees were notified, via letter dated June 20, 2005, of the problem and to return all non-expired product. |
| Distribution | Nationwide, Australia, Brazil, Canada, Chile, China, Dubai, Hong Kong, India, Korea, Mexico, Netherlands, South Africa and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993021 | METRX SYSTEM Surgical Navigation Technologies, Inc., Nov 10, 1999 |