Events

Recall of Device Recall Flexgard, offtheshelf knee brace

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

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
    25659
  • Event Risk Class
    Class 2
  • Event Number
    Z-0658-03
  • Event Initiated Date
    2003-02-14
  • Event Date Posted
    2003-03-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26221
  • 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
    Joint, Knee, External Brace - Product Code ITQ
  • Reason
    Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use.
  • Action
    The firm notified its consignees by letter dated 2/19/2003 asking them to return any in-stock product and to contact their consignees if the product was further distributed.

Device

Device Recall Flexgard, offtheshelf knee brace
  • Model / Serial
    Product number 14761106, Lot numbers: 53078 and 53985
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    ID, CA, NC, TX, SC, NM, GA and TN
  • Product Description
    Flexgard, off-the-shelf knee brace, product number 14761106
  • Manufacturer
    De Royal Industries

Manufacturer

De Royal Industries
  • Manufacturer Address
    De Royal Industries, 870 Industrial Way, San Luis Obispo CA 93401
  • Source
    USFDA