FDAFDA · Alimentos y medicamentos·N.º oficial Z-0615-2014
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.
Publicado el 8 de enero de 2014 · Inicio del retiro: 15 de abril de 2013
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
Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The "on" and "lock" labels were interchanged.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Synthes USA HQ, Inc.
- Distribuidor
- Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada. .
- Lote
- Part Number 05.001.012, lot number AV18166
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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