Events

Recall of Device Recall REFlex VSP Prosthetic foot

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

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
    36883
  • Event Risk Class
    Class 2
  • Event Number
    Z-0468-2007
  • Event Initiated Date
    2006-11-03
  • Event Date Posted
    2007-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49508
  • 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
    Prosthetic foot - Product Code ISH
  • Reason
    Inner tube breakage: distributed low quality units can lead to breakage of the inner tube, resulting in an abrupt rotation of the shock module, compromising function and stability of the prosthetic foot.
  • Action
    By letter on Nov 9, 2006. An initial letter was sent to all involved customers stating the invoice number, the purchase order number and the original shipping date. The problem is explained and the detailed exchange process is outlined. Contact information is included (ref. enclosure 2.1). At the same time as the mailing, all customers are being contacted proactively by a customer service representative.

Device

Device Recall REFlex VSP Prosthetic foot
  • Model / Serial
    Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007. Inner tube serial numbers beginning with 1472 through 1677 are suspect. This number is not traceable to the customer. The recall will be based on shipments made during the period that these numbers were in use. (sold between 25th of August and October 2006)
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide in US plus Worldwide distribution in Canada, Austria, Switzerland, Czech Republic, Germany, Spain, France, United Kingdom, Greece, Israel, Italy, Netherlands and Norway.
  • Product Description
    Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007
  • Manufacturer
    Ossur

Manufacturer

Ossur
  • Manufacturer Address
    Ossur, Grjothals 5, Reykjavik Ireland
  • Source
    USFDA