FDAFDA · Alimentos y medicamentos·N.º oficial Z-0653-2013
UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler.
Publicado el 16 de enero de 2013 · Inicio del retiro: 14 de marzo de 2012
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
Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.
Qué hacer
Voluntary: Firm initiated
Detalles del retiro
- Fabricante
- Surgical Tissue Network, Inc.
- Distribuidor
- Worldwide Distribution including Turkey, Greece, & Mexico.
- Lote
- Product Code: RT53010 Tissue ID: 07-175-330 through 07-175-359; TN61032-11-0017 through TN61032-11-0041; TN62034-11-0001 through TN62034-11-0024; TN62053-11-0155 through TN62053-11-0209; TN67049-11-0291 through TN67049-11-0316; TN70037-11-0020 through TN70037-11-0037; TN74060-11-0021 through TN74060-11-0047; TN74060-11-0050 through TN74060-11-0056
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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