Events

Safety Alert for metal and PEEK suture anchors

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Smith and Nephew.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-08-08
  • Event Date Posted
    2012-08-08
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120808a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: smith and nephew metal and peek suture anchors medical device manufacturer, smith and nephew, has issued a field safety notice concerning metal and peek suture anchors. many of the affected products are from the bioraptor™, footprint, healicoil™ and twinfix™ product lines. according to the manufacturer, there was a class ii recall for certain metal and peek suture anchors due to a packaging issue. specifically, the manufacturer has identified pin holes in a small number of pouches, which constitutes a breach of the sterile barrier. according to the local supplier, smith and nephew, the affected devices were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 8 august 2012.

Device

metal and PEEK suture anchors
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Smith and Nephew metal and PEEK suture anchors
  • Manufacturer
    Smith and Nephew

Manufacturer

Smith and Nephew