AdVance"Male Sling System — Class II medical device recall Z-0806-2015
Terminated recall by American Medical Systems, Inc., reported 2014-12-24, distributed nationwide. During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situ
| Recall number | Z-0806-2015 |
|---|---|
| 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 | 2014-10-15 |
| Classified | 2014-12-16 |
| Reported by FDA | 2014-12-24 |
| Terminated | 2015-05-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CL, CR, DE, EE, ES, FI, FR, GB, GR, HK, HR, IE, IL, IT, LB, MY, NL, NO, NZ, PA, PH, PL, PT, RS, SA, SE, SG, SI, TH, TR, VE, ZA |
| Quantity | 10,085 |
| Reason classes | sterility |
| Serial numbers | 767189001, 878849001, 904928030, 905578100 |
| Model numbers | 720088-01, 720163-01 |
Product
AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The AdVance Male Sling System consists of two, sterile single-use surgical instruments called helical needle passers and a mesh sling with attached connectors. One end of each helical needle passer is keyed to allow a secure attachment of the sling connectors. The sling mesh is constructed of polypropylene monofilament mesh that is precut to 1.2 centimeters arm width, 3.55 centimeters center width, and 35.5 centimeters length. Two absorbable tensioning sutures are threaded into the length of the mesh. Plastic sheaths are placed over each arm of the mesh to aide in ease of placement. The connectors are attached to the ends of the helical needle passers during the procedure. The mesh and suture portions of the sling are intended to remain in the body as a permanent implant and the mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.
Reason for recall
During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components supplied with the AdVance" Male Sling System; Model # 720088-01; AdVance" XP Male Sling System; Model # 720163-01; Monarc" C Subfacial Hammock; Model # 72404195; Monarc" + Subfacial Hammock; Model #
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-0806-2015. 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.