FDAFDA · Alimentos y medicamentos·N.º oficial Z-3100-2017
smith&nephew POLARSTEM(TM) Femoral Stems with Ti/HA (Standard, Lateral, Valgus and Collar), REF 76102260, NON STERILE, QTY: (1), Rx only The subject cardan is used in conjunction with a curved stem impactor used to implant the POLARSTEM hip stem. The hip stem is mounted on the screw at the tip of the instrument, and the stem is then impacted into the femur. After impaction, the surgeon uses a knob at the end of the cardan to unscrew the implanted stem from the instrument
Publicado el 6 de septiembre de 2017 · Inicio del retiro: 24 de julio de 2017
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
The Cardan joint of the Polarstem Cardan could potentially fracture or functionally fail after multiple procedures.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Smith & Nephew, Inc.
- Distribuidor
- Worldwide Distribution - US (Nationwide) and Internationally to Australia, Belgium, Norway, and Switzerland.
- Lote
- Lot Numbers: A57835, A57837, A58509, A59084, A59446, A59547, A60948
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States