International Medical Devices Database

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
R1600259
Date
2016-05-30
Event Country
France
Event Source
ANSM
Event Source URL
https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/chirurgie-orthopedique-tetes-ceramique-alumine-biolox-delta-ceramic-head-36mm-standard-neck-type-12-14-taper-biolox-delta-ceramic-head-32mm-standard-neck-type-1-taper-zimmer-biomet-rappel
Notes / Alerts

French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
Extra notes in the data
Action
ANSM has been informed of the implementation of a lot withdrawal action carried out by ZIMMER BIOMET. The affected users received the attached mail (30/05/2016) (189 KB). This safety action is registered at ANSM under the number R1600259.

Device

Biolox Delta Ceramic Head 36mm Standard Neck Type 12/14 Typing;Biolox Delta Ceramic Head 32mm Sta...

Model / Serial
Product Description
medical_device
Manufacturer
Zimmer Biomet

Manufacturer

Zimmer Biomet

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
LAANSM

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

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Recall of Biolox Delta Ceramic Head 36mm Standard Neck Type 12/14 Typing;Biolox Delta Ceramic Head 32mm Standard Neck Type 1 Typing

What is this?

Device

Biolox Delta Ceramic Head 36mm Standard Neck Type 12/14 Typing;Biolox Delta Ceramic Head 32mm Sta...

Manufacturer

Zimmer Biomet