Reported Dec 24, 2014 · Terminated
AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in…
American Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Medical Systems, Inc. · 10700 Bren Rd W · Minnetonka, MN · 55343-9679
Is this the product you have?
- 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.
- Lot codes and dates
- REF 720088-01 Lot/Serial # 878849001 to 904928030 REF 720163-01 Lot/Serial # 767189001 to 905578100
- Amount recalled
- 10,085
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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 #
This product could cause temporary or reversible health problems — stop using it.
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