Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 14, 2012
AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI).
American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling System (AdVance). AMS has recently received a small number of compl…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
American Medical Systems, Inc. recalled AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 … - a moderate-severity action.
AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 … was recalled by American Medical Systems, Inc. in November 14, 2012. Reason: American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling …. Check the official notice for the remedy. Verify recall #Z-0259-2013 with the FDA Devices before acting.
The recall
American Medical Systems, Inc. issued this moderate-severity FDA Devices recall-American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling ….
- Moderate
- severity level
- 5K units
- affected scope
- Class II
- classification
- November 14, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0259-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0259-2013) was formally reported on November 14, 2012, with the manufacturer initiating the action on October 19, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. American Medical Systems, Inc. is listed as the recalling firm, operating out of Minnetonka, MN. Federal records list the affected scope as 4872.
The documented reason for this recall is: American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling System (AdVance). AMS has recently received a small number of complaints regarding the resorbable suture in… Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of Austria, Australia, Brazil, Canada, Germany, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Croatia, India, Morocco, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
4872
Related Recalls
6
3 from same agency
Product description
AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI).
Reason for recall
American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling System (AdVance). AMS has recently received a small number of complaints regarding the resorbable suture in the AdVance sling not lasting for the entire 15 month shelf life of the product. An internal investigation has been conducted and confirmed that some sutures degraded prior to the
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0259-2013 |
| Date reported | November 14, 2012 |
| Date initiated | October 19, 2012 |
| Recalling firm | American Medical Systems, Inc. |
| Firm location | Minnetonka, MN |
| Affected scope | 4872 |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of Austria, Australia, Brazil, Canada, Germany, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Croatia, India, Morocco, Mexico, Malaysia, Ne… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0259-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI).. Recalled by American Medical Systems, Inc.. Units affected: 4872.
Why was this product recalled? ▼
American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling System (AdVance). AMS has recently received a small number of complaints regarding the resorbable suture in the AdVance sling not lasting for the entire 15 month shelf life of the product. An internal investigation has been conducted and confirmed that some sutures degraded prior to the
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 14, 2012. Severity: Moderate. Recall number: Z-0259-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of Austria, Australia, Brazil, Canada, Germany, Estonia, Spain, Finland, France, Great Britain, Hong Kong, Croatia, India, Morocco, Mexico, Malaysia, Netherlands, New Zealand, Panama, Poland, Russian Federation, Solomon Islands, Singapore, Thailand, Turkey, Venezuela, South Africa, Chile, Colombia, Costa Rica, Slovenia, Argentina, China, and Taiwan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0259-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 14, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.