Events

Recall of Arthrex - Bio-Pushlock, SwiveLock - Anchors, 7

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Arthrex 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
    21291
  • Event Initiated Date
    2017-04-06
  • 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: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Reason
    The manbufacturer has recently determined that there is an issue with the self-punching eyelet contained within the arthrex swivelock sp suture anchor. this may cause the eyelet to break on insertion in hard bone.
  • Action
    Product to be exchanged

Device

Arthrex - Bio-Pushlock, SwiveLock - Anchors, 7
  • Model / Serial
    Model: , Affected: Arthrex SwivelLock SP Suture Anchor
  • Manufacturer
    Arthrex Inc

Manufacturer

Arthrex Inc