FDAFDA · Alimentos y medicamentos·N.º oficial Z-2530-2016
Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details of the tooth anatomy and deposits below the gum line (i.e. calculus root fractures, restoration margins, tooth decay).
Publicado el 24 de agosto de 2016 · Inicio del retiro: 24 de junio de 2016
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 Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Danville Materials, Inc.
- Distribuidor
- US and New Zealand, Australia, Canada, Japan, Israel, United Kingdom, Italy, Mexico.
- Lote
- Part number 1008: Lot numbers: 1133; 1135; 1136; 1137; 1138; 1163; 1171; 1172; 1173; 1174; 1175; 1218; 1240; 1243; 1258; 1264; 1264-1; 1275; 1276; 1277; 1311; 1314; 1315; 1325; 1326.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States