FDAFDA · Alimentos y medicamentos·N.º oficial Z-2004-2016
Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.
Publicado el 13 de julio de 2016 · Inicio del retiro: 21 de abril 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
AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an unsealed Tyvek pouch. The non-sterile foil pouch may introduce contamination into the sterile field.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Musculoskeletal Transplant Foundation, Inc.
- Distribuidor
- nationwide
- Lote
- Serial 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States