Events

Recall of REFLEX ROTATE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OSSUR HF.

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
    121636
  • Event Risk Class
    II
  • Event Initiated Date
    2015-07-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Recent findings suggest that non-ossur female mating adapters connected to ossur ankle male pyramids have caused early failure of the male pyramid connector. this is due to incompatible geometry of the female mating adaptors used and/or improper set up of the prothesis.

Device

REFLEX ROTATE
  • Model / Serial
    Model Catalog: >30 CONTACT MFG (Lot serial: n/a); Model Catalog: >10 CONTACT MFG (Lot serial: n/a)
  • Product Description
    Re-Flex Rotate
  • Manufacturer
    OSSUR HF

Manufacturer

OSSUR HF
  • Manufacturer Address
    REYKJAVIK
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    HC