Events

Recall of Device Recall Genzyme Biosurgery Essentials Kit, Item Number 82004

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

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
    56218
  • Event Risk Class
    Class 2
  • Event Number
    Z-2310-2010
  • Event Initiated Date
    2010-07-13
  • Event Date Posted
    2010-08-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92974
  • 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
    General Surgery Tray - Product Code LRO
  • Reason
    Revised labeling of carticel essentials kit clarifies the non-sterile packaging of the outer clear plastic tray which should not be opened in the sterile field.
  • Action
    Genzyme notiifed physicians with the Dear Doctor letter on July 13, 2010 via UPS Ground delivery. The letter informed healthcare workers of the recent incidents and advise them to heed the Essentials Kit label and exercise proper handling of the Kit.. A fax return form will be provided for the physician to sign and return to Genzyme to acknowledge receipt of the notification. Contact Genzyme Medical Information at 800-453-6948, option #3 for any additional information or contact your Genzyme sales representative with any questions.

Device

Device Recall Genzyme Biosurgery Essentials Kit, Item Number 82004
  • Model / Serial
    Lot Numbers Affected: RM00654  RM00664  RM00672  RM00687  RM00690  RM00698  RM00700  RM00711  RM00714  RM00727  RM00732  RM00741  RM00748  RM00757  RM00773  RM00781  RM00791  RM00802 RM00820 RM00835
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Genzyme Biosurgery Essentials Kit, Item Number 82004
  • Manufacturer
    Genzyme Corporation

Manufacturer

Genzyme Corporation
  • Manufacturer Address
    Genzyme Corporation, 64 Sidney Street, Cambridge MA 02139
  • Manufacturer Parent Company (2017)
    Sanofi
  • Source
    USFDA