SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
Publicado el 20 de abril de 2016 · Inicio del retiro: 8 de diciembre de 2015
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
It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a SYNTHECEL implant. SYNTHECEL Dura Repair labeling and promotional material are being updated to clarify that SYNTHECEL is intended to remain in place and is not intended to be removed.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Synthes (USA) Products LLC
- Distribuidor
- Nationwide: NY, PA, AL, WI, FL, MO, TN, OH, MI, MN, CO, CA, NV, AZ, LA, OR, TX, IA, IN, MS, IL, AR, WV, HI, VA, MD, WA, OK, MA, KY, NJ, CT, No foreign accounts.
- Lote
- SYNTHECEL Dura Repair 5.0 cm x 5.0 cm (2x2), part numbers: SC.400.025.01S, Lot Numbers: 7840495, 7855339, 7860566, 7880950, 7900039, 7909573, 7922342, 7932416, 7984107
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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