Events

Recall Or Safety Alert for "Biolox Delta ceramic head 28 mm-3.5 mm neck" reference 650-0830 and lot 3256398, and "Biolox Delta 28 mm ceramic head - standard collars", reference 650-0831, lot 3243206, manufactured by Biomet UK, United Kingdom

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by Biomet UK, Reino Unido.

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
    Recall / Safety Alert
  • Date
    2015-02-12
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    Withdrawal from market of batch 3256398, reference 650-0830, and batch 3243206, reference 650-0831 of the "Biolox Delta 28 mm Ceramic Heads", because the product may not correspond to the reference in the labeling

Device

"Biolox Delta ceramic head 28 mm-3.5 mm neck" reference 650-0830 and lot 3256398, and "Biolox Del...

Manufacturer

Biomet UK, Reino Unido
  • 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
    AEMPSVFOI