| Date Initiated by Firm | June 19, 2006 |
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| Date Posted | July 13, 2006 |
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| Recall Status1 |
Terminated 3 on January 10, 2008 |
| Recall Number | Z-1227-06 |
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| Recall Event ID |
35765 |
| 510(K)Number | K990723 |
|---|
| Product Classification |
Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
|
| Product | TriVex 200LV Resector Kit, 5.5
Part Number: 7209271 |
|---|
| Code Information |
Lot Numbers: All lot numbers lower than 50156900 Expanded recall: Lot Numbers: 50173181, 50175084 |
Recalling Firm/
Manufacturer |
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
|
| For Additional Information Contact | Jason Bilobram
978-474-6332 |
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Manufacturer Reason
for Recall | The sterility seal of the package trays may have incomplete seals compromising the sterility of the device |
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FDA Determined
Cause 2 | Other |
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| Action | Smith & Nephew initiated the recall by Certified Letter on June 19, 2006 requesting return of the recalled products.
Smith & Nephew expanded the recall to include additional lots. The firm issued the recall expansion letter dated 8/25/06. |
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| Quantity in Commerce | 2856 units/Expanded 207 units |
|---|
| Distribution | Nationwide and Austria, China, Germany, Finland, Italy, South Africa, South Korea, Switzerland, UK. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
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 = GEI
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