Events

Recall of Device Recall LP Rotate Foot System

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

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
    70648
  • Event Risk Class
    Class 2
  • Event Number
    Z-1288-2015
  • Event Initiated Date
    2015-03-04
  • Event Date Posted
    2015-03-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134240
  • 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
    The threads of the outer tube of the shock module of lp rotate are too short, resulting in insecure assembly. use of the product may cause the patient to fall with continued use, as the shock module can become loose from the foot blade.
  • Action
    The firm's recall letter states the following instructions: Immediately examine inventory and quarantine product subject to the recall. In addition the firm asks if further distributed to identify the customers and notify them of the recall. The firm states that notification may be enhanced by providing a copy of the letter. The firm states that the recall notice needs to be passed along to all those who need to be aware. The firm also states that if customers are wearing a faulty product that they recommend them scheduling a visit to have the product replaced with a new LP Rotate that is currently available. The firm states that they can also arrange pick-up of defected products. For any questions the firm provides a customer service contact: Jamie Dutter, Senior Customer Service Representative.

Device

Device Recall LP Rotate Foot System
  • Model / Serial
    LP Rotate, sizes 25-27 cat.1-6. Product numbers LRP062, LRF062, LRPU62, LRFU62. All from manufacturing lot number HF141022
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide within the U.S. and internationally to the following foreign countries; Belgium, United Kingdom, Germany, Czech Republic, France, Israel, Poland, Spain, Australia, Japan, Mexico, Bulgaria, Canada, South Korea, Sweden, Finland,
  • Product Description
    LP Rotate Foot System prosthetic device for fitting lower extremity amputations. || -Low profile foot module with adjustable shock absorber and rotation || with progressive stiffening || -Build height: with male pyramid adapter 145 - 153mm (5 11/16 - 6 ) || with female pyramid adapter 153 165mm (6 - 6 1/2) || -Male pyramid adapter || -Female pyramid adapter || -Maintenance free, no lubrication required || -Maximum weight: 147kg (325lbs) || -Available in sizes 22-30
  • Manufacturer
    Ossur H / F

Manufacturer

Ossur H / F
  • Manufacturer Address
    Ossur H / F, Grjothals 5, Reykjavik Iceland
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    USFDA