Events

Safety Alert for ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Smith & 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
    2015-05-05
  • Event Date Posted
    2015-05-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150505a.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 & nephew ultra fast-fix knot pusher/suture cutter, straight medical device manufacturer, smith & nephew, inc., has issued a medical device safety alert concerning ultra fast-fix knot pusher/suture cutter, straight. [product number: 72201537; batch number: all batches manufactured from april 2010 to april 2014 which have corresponding expiration dates of april 2015 to april 2019]. the manufacturer’s internal investigation has found that the packaging material and design to be insufficient to prevent the ultra fast-fix knot pusher suture cutter’s sharp edges from potentially puncturing the pouch and rendering the device unsterile. an unsterile device used during an arthroscopic repair could potentially lead to a post-operative infection. product recall is ongoing. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 may 2015.

Device

ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Smith & Nephew ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight
  • Manufacturer
    Smith & Nephew

Manufacturer

Smith & Nephew