Events

Recall of Ossur LP rotate, sizes 25-27 cat.1-6

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    18538
  • Event Initiated Date
    2015-07-23
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Christchurch Artificial Limb Centre, 330 Burwood Road, Christchurch 8083
  • Reason
    Ossur is recalling this device due to the outer tube threads not being machined correctly. use of the affected product may cause the patient to fall, as the shock module can become loose from the foot blade. the failure could possibly be noticed by users as they will feel looseness on ankle foot device. if use is continued, connection of shock adapter to foot blade might break and user may fall.
  • Action
    Product to be returned to supplier

Device

Ossur LP rotate, sizes 25-27 cat.1-6
  • Model / Serial
    Model: Product numbers LRP062, LRF062, LRPU62, and LRFU62, Affected: Manufacturing Lot Number: HF141022
  • Manufacturer
    Ossur HF

Manufacturer

Ossur HF
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    NZMMDSA