FDA Device recall Z-0806-2015
AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The AdVance M…
- FDA Device
- Class II
- terminated
- Published 2014-12-24
On 2014-12-24 the FDA classified a Class II recall of AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The AdVance M… by American Medical Systems, citing during routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0806-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-15 |
| Published | 2014-12-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | American Medical Systems |
| Distribution | US |
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
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 #
Identifiers
| code_info | REF 720088-01 Lot/Serial # 878849001 to 904928030 REF 720163-01 Lot/Serial # 767189001 to 905578100 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0806-2015%22
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