Device Recall ZCORE Syringe

  • Modelo / Serial
    PMCS025   Lot No. PMCSU15A1  PMCS05  Lot No. PMCSU15A1   PMCS10  Lot No. PMCSU15A1  PMCS05  Lot No. PMCSU15A2    PMCS10 Lot No. PMCSU15A2
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US in the state of TX
  • Descripción del producto
    ZCORE Porcine Xenograft Particulate in Syringe || Product Intended for use in dental surgery such as: || -Augmentation or reconstructive treatment of alveolar ridge || -filling of defects after root resection, apicoectomy and cystectomy || -Filling of extraction sockets to enhance preservation of the alveolar ridge || -elevation of maxillary sinus floor || -Filling of periodontal defects in conjunction with products || -Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) || -Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Collagen Matrix Inc, 509 Commerce St, Franklin Lakes NJ 07417-1374
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA