U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Biomet is recalling active articulation e1 hip bearing implants. biomet has initiated this action following an investigation which identified that outer label indicates two conflicting o.D. sizes while the inner labels indicate an incorrect o.D. size.
the implant itself is etched with the correct o.D. size.
조치
Biomet sent an Urgent Medical Device Recall letter dated April 26, 2013 to consignees detailing that the outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. This action requires the immediate location and discontinued use of the product and its return to Biomet. Ciustomers were advised to:
Immediately locate and remove the identified device(s) listed from circulation .
-Carefully follow the instructions on the enclosed "FAX Back Response Form" .
- Fax a copy of the Response Form to 574-372-1683 prior to return of product.
-Use priority carrier for your shipment.
- If you have further distributed this product, you MUST notify hospital personnel of this action via the enclosed "Dear O.R. Manager" notice. This letter MUST be given to hospital personnel responsible for receiving recall notices. However, you are charged with the location and return of these products.
Part numbers: EP-200162, EP-200162, EP-200164, and EP-200166 with Lot numbers: 027050, 101470, 115950, 101480, 247990, 948810, 967270, 027070, 287820, 729870, and 860880.
“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.