| | Class 2 Device Recall Metrx |  |
| Date Initiated by Firm | June 20, 2005 |
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| Date Posted | July 13, 2005 |
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| Recall Status1 |
Terminated 3 on February 08, 2006 |
| Recall Number | Z-0993-05 |
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| Recall Event ID |
32511 |
| 510(K)Number | K993021 |
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| Product Classification |
arthroscopy - Product Code HRX
|
| Product | Medtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030. |
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| Code Information |
All lots. |
Recalling Firm/
Manufacturer |
Warsaw Orthopedic, Inc.
2500 Silveus Xing
Warsaw IN 46582-8598
|
| For Additional Information Contact |
800-876-3133 Ext. 4668 |
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Manufacturer Reason
for Recall | The package is labeled as sterile, but there may be a hole in the immediate package caused by the carton design. |
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FDA Determined
Cause 2 | Package design/selection |
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| Action | Consignees were notified, via letter dated June 20, 2005, of the problem and to return all non-expired product. |
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| Distribution | Nationwide, Australia, Brazil, Canada, Chile, China, Dubai, Hong Kong, India, Korea, Mexico, Netherlands, South Africa and Taiwan. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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| 510(K) Database | 510(K)s with Product Code = HRX
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