Events

Recall of Fixed Offset Adapter, A642100

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
    66609
  • Event Risk Class
    Class 2
  • Event Number
    Z-0362-2014
  • Event Initiated Date
    2013-10-24
  • Event Date Posted
    2013-11-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122724
  • 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
    Ossur inititated a voluntary recall of the a-642100 fixed offset adapter because it can develop fatigue cracks in normal use over an extended period of time and ultimately separate completely.
  • Action
    Ossur sent an "Safety Notice Voluntary Product Recall" letter dated October 29, 2013, via regular mail. Follow-up telephones are also made. The letter identified the product the problem and the actions to be taken by the customer. ¿ssur is committed to providing superior customer service and we will do our utmost to minimize any inconvenience this may cause your practice. To ensure patient safety we kindly ask you to take the following action: " Please identify the users of each of the A-642100 adapters, see attached list. " Also, please check your inventory for any A-642100s you may have on hand but have not fitted on users. A follow-up phone call will be made a few days later to coordinate replacements. A new replacement component will be provided to the customer. For further questions please call (949) 360-3634.

Device

Fixed Offset Adapter, A642100
  • Model / Serial
    Item Number: A-642100    All Serial Numbers.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of AL, TX, NY, CA, VA, GA, WI, NC, ID and NJ.
  • Product Description
    Fixed Offset Adapter, A-642100. || The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy with a pyramid receiver and is intended where there is a need to offset the tube horizontally in relation to other components. It is fully compatible with all standard 30mm prosthetic pylons. (3) Offset: 14,5mm (0.57inch).
  • Manufacturer
    Ossur North America Inc

Manufacturer

Ossur North America Inc
  • Manufacturer Address
    Ossur North America Inc, 27051 Towne Centre Dr, Foothill Ranch CA 92610-2804
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    USFDA