AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling… — Class II medical device recall Z-0259-2013
Terminated recall by American Medical Systems, Inc., reported 2012-11-14, distributed nationwide. American Medical Systems¿ (AMS) is issuing a voluntary recall on a number of lots of the AdVance¿ Male Sling S
| Recall number | Z-0259-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Medical Systems, Inc., Minnetonka, MN, United States |
| Recall initiated | 2012-10-19 |
| Classified | 2012-11-07 |
| Reported by FDA | 2012-11-14 |
| Terminated | 2013-04-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BR, CA, CL, CN, CO, CR, DE, EE, ES, FI, FR, GB, HK, HR, IN, MA, MX, MY, NL, NZ, PA, PL, SG, SI, TH, TR, TW, VE, ZA |
| Quantity | 4,872 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0259-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.