FDAFDA · Alimentos y medicamentos·N.º oficial Z-1479-2020
COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos. NN081K NN082K NN083K NN084K NN085K NN086K NN087K NN088K NN089K Product Usage: Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer.
Publicado el 25 de marzo de 2020 · Inicio del retiro: 21 de enero de 2020
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
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Aesculap Implant Systems LLC
- Distribuidor
- Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, OH, OK, OR, PA, TN, TX, UT, WA and countries of Saudi Arabia, Utd. Arab Emir., Argentina, Austria, Australia, Bosnia-Herz., Bulgaria, Brazil, Switzerland, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Germany, Algeria, Ecuador, Estonia, Spain, United Kingdom, Georgia, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Libya, Moldavia, Mexico, Malaysia, Nigeria, Netherlands, Poland, Portugal, Paraguay, Russian Fed., Singapore, El Salvador, Thailand, Turkey, Ukraine, South Africa.
- Lote
- All product with old packaging configuration. New packaging configuration begins with Lot 52533610.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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