| | Class 2 Device Recall Vesica |  |
| Date Initiated by Firm | June 02, 2006 |
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| Date Posted | August 02, 2006 |
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| Recall Status1 |
Terminated 3 on April 17, 2007 |
| Recall Number | Z-1308-06 |
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| Recall Event ID |
35724 |
| 510(K)Number | K932925 |
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| Product Classification |
Staple, Fixation, Bone - Product Code JDR
|
| Product | Boston Scientific Vesica Sling Kits with Drill-In Anchor System sterile, for single use only; Ref/Catalog No. 820-100, UPN Product No. (M0068201000). |
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| Code Information |
Lots 8555778, 8552615 and 8718072. |
| FEI Number |
1828132
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Recalling Firm/
Manufacturer |
Boston Scientific Corp
780 Brookside Dr
Spencer
IN
47460-1080
|
| For Additional Information Contact |
508-683-4186 |
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Manufacturer Reason
for Recall | The packages are labeled sterile, but the product was not sterilized. |
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FDA Determined
Cause 2 | Other |
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| Action | Consignees were notified by letters dated 6/2/06 and sent via Federal Express and requesting return of the products. |
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| Quantity in Commerce | 22 kits. |
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| Distribution | Nationwide, including California, Florida, Kansas, North Carolina, Oklahoma, South Dakota, Tennessee, West Virginia and Wisconsin. |
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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 = JDR
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