Reported Dec 24, 2014 · Terminated
AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning…
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?
- AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. The Monarc + and Monarc C subfascial hammocks are sterile, single use procedure kits, each consisting of two stainless steel, curved needle passers. The tip portion of each needle passer is configured to allow for secure placement of the connectors. Each needle passer has a plastic handle attached. The system also contains a sling assembly including one piece of loosely knitted polypropylene mesh, two removable plastic insertion sheaths attached to the mesh, and two connectors attached to the insertion sheaths. The mesh is constructed of polypropylene monofilament. An absorbable tensioning suture is threaded into the length of the mesh to allow for tensioning adjustment of the mesh after placement in the patient is achieved. The plastic covering also affords convenient travel of the mesh through the tissue. The connectors are attached to the tip portions of the Monarc needle passers during the procedure. The loosely knitted polypropylene mesh is intended to remain in the body as a permanent implant. The mesh component is not absorbed or degraded by the action of tissue in-growth or tissue enzymes.
- Lot codes and dates
- REF 72404195 Lot/Serial 858296001 to 897413030; REF 72404193 Lot Serial 858292001 to 906172040
- Amount recalled
- 2,165
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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