Events

Recall of Device Recall SynviscOne

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sanofi Genzyme.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78792
  • Event Risk Class
    Class 2
  • Event Number
    Z-0607-2018
  • Event Initiated Date
    2017-12-11
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160495
  • Notes / Alerts
    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.
  • Extra notes in the data
    Acid, hyaluronic, intraarticular - Product Code MOZ
  • Reason
    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
  • Model / Serial
    Lot Number: 7RSL021 Expiration Date: 2020-05-31
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    US Nationwide distribution(36 states)
  • Product Description
    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
  • Manufacturer Address
    Sanofi Genzyme, 500 Kendall St, Cambridge MA 02142-1108
  • Manufacturer Parent Company (2017)
    Sanofi-Genzyme BioVentures
  • Source
    USFDA