FDAFDA · Alimentos y medicamentos·N.º oficial Z-0401-2013
BioPlant, a dental bone grafting material. BioPlant has been assigned the product code LYC (Bone Grafting Material, Synthetic) by the FDA and is classified as a Class II Medical Device. BioPlant is a Class II Medical Device. The Device Listing Number is 0007254. BioPlant is a synthetic, multipurpose bone-grafting material intended to be used in dental applications to maintain and restore the bony alveolar ridge in post-extraction tooth-root sockets or after oral surgery, ridge preservation, ridge augmentation, augmentations in the maxillary sinus, repair of periodontal defects and bone voids associated with dental implant placement.
Publicado el 28 de noviembre de 2012 · Inicio del retiro: 25 de octubre 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
The firm initiated the recall becaue disturbing the BioPlant product soon after it is placed may halt or delay the ossification process.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Kerr Corporation
- Distribuidor
- Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees .
- Lote
- The BioPlant part numbers and lot numbers affected by this recall are as follows: Product Description Part Numbers Lot Numbers BioPlant Curved Syringe, 0.125g 216110 All Production BioPlant Curved Syringe, 0.25g 216112 BioPlant Curved Svrinoe, 0.50<1 216114 Lots Within Shelf-Life BioPlant Curved Svrinoe, 0.250 216132 20k BioPlant Intro Pack 216112S
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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