| | Class 2 Device Recall METRx II Tube |  |
| Date Initiated by Firm | January 25, 2006 |
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| Date Posted | April 12, 2006 |
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| Recall Status1 |
Terminated 3 on July 05, 2007 |
| Recall Number | Z-0733-06 |
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| Recall Event ID |
34653 |
| Product Classification |
Orthopedic Manual Surgical Instrument - Product Code LXH
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| Product | METRx II Tube, 18mm x 3cm stainless steel tubular retractor, Part No. 9569680 |
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| Code Information |
Lot No. FA05K017 |
| FEI Number |
3004564008
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Recalling Firm/
Manufacturer |
Medtronic Sofamor Danek Instrument Manufacturing
2975 Brother Blvd
Bartlett TN 38133-3957
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| For Additional Information Contact | Bert Kelly
901-396-3133 |
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Manufacturer Reason
for Recall | Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off. |
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FDA Determined
Cause 2 | Other |
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| Action | The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product. |
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| Quantity in Commerce | 4 |
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| Distribution | IL, IN, MI, CA, Japan, Netherlands |
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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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