FDAFDA · Alimentos y medicamentos·N.º oficial Z-2032-2014
Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process.
Publicado el 16 de julio de 2014 · Inicio del retiro: 12 de junio 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
Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Zimmer Manufacturing B.V.
- Distribuidor
- Worldwide Distribution - USA (nationwide) and the countries of India, Japan, China, Australia and Canada.
- Lote
- Lot No. 62629432 Lot No. 62628759
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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