Events

Recall of Device Recall Icelock Expulsion Valve 551

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ossur Engineering, 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
    52773
  • Event Risk Class
    Class 2
  • Event Number
    Z-2026-2009
  • Event Initiated Date
    2009-06-23
  • Event Date Posted
    2009-09-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83976
  • 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
    Prosthesis Valve - Product Code ISP
  • Reason
    The plastic caps have come off or become loose when the user stepped into their prosthesis.
  • Action
    Customers were sent a Safety Notice Voluntary Product Recall, dated June 23, 2009, that advised them to return any unused valves to Ossur for a free replacement. Those using valves in combination with a cushion liner and suspension sleeve should replace immediately if problems are experienced, otherwise replace at next routine service. Customers using valve in combination with an Iceross Seal-In liner should replace ASAP and return used valves to Ossur for free replacement. Customers with questions can call Darlyne Roa 1-800-233-6263 ext 1023743.

Device

Device Recall Icelock Expulsion Valve 551
  • Model / Serial
    Lot CO081010
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    Icelock Expulsion Valve 551 Model L-551000 || The valve has a push button for suction release to release a lower limb prosthesis.
  • Manufacturer
    Ossur Engineering, Inc

Manufacturer

Ossur Engineering, Inc
  • Manufacturer Address
    Ossur Engineering, Inc, 910 Burstein Dr, Albion MI 49224-4011
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    USFDA