Events

Retiro De Equipo (Recall) de BioPlant

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Kerr Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    63557
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0401-2013
  • Fecha de inicio del evento
    2012-10-25
  • Fecha de publicación del evento
    2012-11-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-09-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114201
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Bone grafting material, synthetic - Product Code LYC
  • Causa
    The firm initiated the recall becaue disturbing the bioplant product soon after it is placed may halt or delay the ossification process.
  • Acción
    Kerr Corporation sent an Urgent Medical Device Correction letter and acknowledgement form dated October 25, 2012, to all affected customers via USPS First Class. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: "...review the table with product description , part numbers and lot numbers to determine if they have any of the affected product in their inventory and confirm that they were aware of the additional placement instructions necessary to achieve desired ossification results detailed in the paragraph in the letter. Customers were instructed to contact Kerr Customer Care at 1¿800¿537¿7123 if they have any questions. Customers were also instructed to complete and fax back the enclosed Acknowledgement Form to 714-288-4609 in order to confirm their receipt of this correction regardless of whether they have any affected product in their inventory. For questions regarding this recall call 714-516-7400.

Device

BioPlant
  • Modelo / Serial
    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 del producto
    Dental Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) Canada, Europe, Australia and ROW consignees .
  • Descripción del producto
    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.
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation
  • Dirección del fabricante
    Kerr Corporation, 1717 W Collins Ave, Orange CA 92867-5422
  • Empresa matriz del fabricante (2017)
    Danaher Corporation
  • Source
    USFDA