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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0198-2015

Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to:  Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.  Collagen disorders, and/or avascular necrosis of the femoral condyle.  Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.  Moderate valgus, varus, or flexion deformities.  The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.  This device is intended for cemented use only.

Publicado el 19 de noviembre de 2014 · Inicio del retiro: 9 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

Cleaning process validation failure.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Zimmer, Inc.
Distribuidor
US Nationwide Distribution and countries of Austria ,Belgium, Switzerland, Germany, France, United Kingdom, Italy and South Africa.
Lote
Part Number 42-5320-079-02 Lot Number 62613813 Part Number 42-5320-071-02 Lot Number 62625781 Part Number 42-5320-075-01 Lot Number 62619031 Part Number 42-5320-075-01 Lot Number 62619040 Part Number 42-5320-079-01 Lot Number 62626696 Part Number 42-5320-071-01 Lot Number 62625790
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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