| Date Initiated by Firm | July 28, 2003 |
|---|
| Date Posted | July 20, 2004 |
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| Recall Status1 |
Terminated 3 on June 22, 2004 |
| Recall Number | Z-1019-04 |
|---|
| Recall Event ID |
29142 |
| 510(K)Number | K023516 |
|---|
| Product Classification |
Mesh, Surgical, Polymeric - Product Code FTL
|
| Product | Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1 |
|---|
| Code Information |
Lot/serial number 372128/001-030 (domestic) and 374329/001-032 (international) |
| FEI Number |
1000116179
|
Recalling Firm/
Manufacturer |
American Medical Systems
10700 Bren Rd W
Minnetonka MN 55343-9679
|
| For Additional Information Contact | Therese A. Bowker
952-930-6624 |
|---|
Manufacturer Reason
for Recall | Insertion needles from the former version of the product were packaged with the new sling with dilator that is different than the old version and not compatible with the old needles. |
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FDA Determined
Cause 2 | Other |
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| Action | The consignees were informed of the recall by telephone on 7/28/03 and told to return the product for replacement. |
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| Quantity in Commerce | 62 units |
|---|
| Distribution | The product was shipped to consignees in Connecticut, Indiana, MIchigan, North Carolina, Ohio, and Texas in the United States and to Belgium. |
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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.
|
| 510(K) Database | 510(K)s with Product Code = FTL
|
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