Events

Rappel de Device Recall SynviscOne

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Sanofi Genzyme.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    78792
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0607-2018
  • Date de mise en oeuvre de l'événement
    2017-12-11
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160495
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Acid, hyaluronic, intraarticular - Product Code MOZ
  • Cause
    Contamination with methylbacterium thiocyanatum.
  • Action
    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
  • Modèle / numéro de série
    Lot Number: 7RSL021 Expiration Date: 2020-05-31
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide distribution(36 states)
  • Description du dispositif
    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
  • Adresse du fabricant
    Sanofi Genzyme, 500 Kendall St, Cambridge MA 02142-1108
  • Société-mère du fabricant (2017)
    Sanofi-Genzyme BioVentures
  • Source
    USFDA