Events

Recall of Mauch XG, Caron Knee Frame. || Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ossur North America Inc.

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
    25940
  • Event Risk Class
    Class 2
  • Event Number
    Z-0815-03
  • Event Initiated Date
    2003-03-17
  • Event Date Posted
    2003-05-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26747
  • 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 Limb Component - Product Code ISY
  • Reason
    Knee frame defect lead to breakage and injury. knee bolt end came loose.
  • Action
    Firm called customers by phone and sent recall letters 3/17/2003.

Device

Mauch XG, Caron Knee Frame. || Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.
  • Model / Serial
    No lot numbers apply, there are no serial numbers for this product. All frames manufactured since the product was released are suspect.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Mauch XG, Caron Knee Frame. || Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750.
  • Manufacturer
    Ossur North America Inc

Manufacturer

Ossur North America Inc
  • Manufacturer Address
    Ossur North America Inc, 27412 Laguna Hills Dr, Aliso Viejo CA 92656
  • Source
    USFDA