Events

Retiro De Equipo (Recall) de Device Recall SynviscOne

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 Sanofi Genzyme.

¿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
    78792
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0607-2018
  • Fecha de inicio del evento
    2017-12-11
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160495
  • 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
    Acid, hyaluronic, intraarticular - Product Code MOZ
  • Causa
    Contamination with methylbacterium thiocyanatum.
  • Acción
    On December 11, 2017 Sanofi Genzyme distributed URGENT VOLUNTARY DEVICE RECALL notices and reply cards to their customers via courier service. Customers were advised to inspect inventory, immediately discontinue use and return all affected product. On December 19, 2017 Sanofi Genzyme distributed a 2nd notice titled DEVICE RECALL UPDATE NOTICE (2 of 3) notifying customers that the isolated bacterial organism was Methylbacterium thiocyanatum. On December 22, 2017 Sanofi Genzyme distributed a 3rd notice titled DEVICE RECALL UPDATE NOTICE (3 of 3) which included antibiotic sensitivity analysis guidance for the isolated organism. Customers who wish to return product should contact GENCO Pharmaceutical Services at 1-855-838-5782 for a recalled product return kit. Customers are encouraged to complete and return the Business Reply Card via fax to 1-414-459-8791 or via email to recalls@genco.com. Sanofi Genzyme will issue you a credit or replacement product upon receipt of the recalled product by GENCO. All questions of a medical or clinical nature should be directed to Sanofi Medical Information Services in the U.S. at 1-800-633-1610, option 1. Sanofi US Customer service can be reached at 1-800-633-1610 option 7 then 4.

Device

Device Recall SynviscOne
  • Modelo / Serial
    Lot Number: 7RSL021 Expiration Date: 2020-05-31
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    US Nationwide distribution(36 states)
  • Descripción del producto
    Synvisc-One ¿ (hylan G-F 20), 6mL delivered from a 10mL syringe || Product Usage: || A elastoviscous high molecular weight fluid containing hylan A and hylan B polymers produced from chicken combs. Synvisc-One is administered as a single intra-articular injection. Synvisc-One is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.
  • Manufacturer
    Sanofi Genzyme

Manufacturer

Sanofi Genzyme
  • Dirección del fabricante
    Sanofi Genzyme, 500 Kendall St, Cambridge MA 02142-1108
  • Empresa matriz del fabricante (2017)
    Sanofi-Genzyme BioVentures
  • Source
    USFDA