FDAFDA · Alimentos y medicamentos·N.º oficial 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 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.
Publicado el 24 de diciembre de 2014 · Inicio del retiro: 15 de octubre de 2014
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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 #
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- American Medical Systems, Inc.
- Distribuidor
- Worldwide Distribution-US (nationwide) including DC and Puerto Rico and the countries of AUSTRIA, BELGIUM, CROATIA, CECH REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ISRAEL, ITALY, LEBANON, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SAUDI ARABIA, SLOVENIA, SERBIA, SOUTH AFRICA, SPAIN. SWEDEN, SWITZERLAND, TURKEY, UNITED KINGDOM, CHILE, COLUMBIA, COSTA RICA, HONG KONG, MALAYSIA, MARTINIQUE, NEW ZEALAND, PANAMA, PHILIPPINES, SINGAPORE, THAILAND, VENEZUELA, CANADA, AUSTRALIA.
- Lote
- REF 720088-01 Lot/Serial # 878849001 to 904928030 REF 720163-01 Lot/Serial # 767189001 to 905578100
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States