Events

Recall of Shellgel

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

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
    27457
  • Event Risk Class
    Class 3
  • Event Number
    Z-0108-04
  • Event Initiated Date
    2003-10-08
  • Event Date Posted
    2003-11-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29906
  • 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
    Aid, Surgical, Viscoelastic - Product Code LZP
  • Reason
    Stability failure at the 20 month for viscosity specification.
  • Action
    Anika Therapeutics issued notification on 10/8/2003 by fax and FedEx to three Distributors. Distributors were requested to subrecall to their customers.

Device

Shellgel
  • Model / Serial
    Lot Number: B020122B
  • Product Classification
    Ophthalmic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    CA, MO, NC,VA
  • Product Description
    ShellGell Sodium Hyaluronate 0.8mL Syringe, || 12 mg/mL. Sterile. Rx. For intraocular use. || Product Number: 1000 || Distributed by Cytosol Opthalmics, Inc., Lenick, NC
  • Manufacturer
    Anika Therapeutics

Manufacturer

Anika Therapeutics
  • Manufacturer Address
    Anika Therapeutics, 240 West Cummings Park, Woburn MA 01801
  • Source
    USFDA