Events

Safety Alert for Sternalock Blu Implant Tray

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

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
    2012-01-26
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120126b.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
    Field safety notice: biomet microfixation sternalock blu implant tray health canada has issued a type i recall concerning sternalock blu implant tray [model no.: 73-1300, 73-1301, 73-1302; lot no.: 032211, 042911, 100611, 249640, 280130, 280131, 312560, 031411, 011411], manufactured by biomet microfixation, inc. according to the report, the screw measuring area seemed inaccurate and could cause the incorrect screw to be chosen by the medical professionals. it is possible that the screw could come into contact with the lung, heart muscle, or an artery and this could result in a pneumothorax or bleeding. for details, please refer to the health canada website: http://hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_jan-mar_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Sternalock Blu Implant Tray
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biomet Microfixation Sternalock Blu Implant Tray
  • Manufacturer
    Biomet Microfixation

Manufacturer

Biomet Microfixation
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DH