Events

Recall of VSP Shock Module (as part of a prosthetic foot).

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
    29386
  • Event Risk Class
    Class 2
  • Event Number
    Z-1083-04
  • Event Initiated Date
    2004-06-15
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-06-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33652
  • 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
    Component, External, Limb, Ankle/Foot - Product Code ISH
  • Reason
    Flawed shock module might cause breakage causing patient to fall.
  • Action
    Firm will be contacting customers and patients to replace the defective components. Contact will be made by mail and by phone.

Device

VSP Shock Module (as part of a prosthetic foot).
  • Model / Serial
    RFL0001, RFL00008, RFL50006, RFX00001, RFX00002, RFX00012.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    VSP Shock Module (as part of a prosthetic foot).
  • Manufacturer
    Ossur North America Inc

Manufacturer

Ossur North America Inc
  • Manufacturer Address
    Ossur North America Inc, 27412 Aliso Viejo Pkwy, Aliso Viejo CA 92656-3371
  • Source
    USFDA