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.
The firm has received reports of fractured heads, requiring revision surgery.
조치
Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated March 16, 2009 to users describing the affected device. Consignees were instructed to locate and discontinue use of the product and quarantine until a sales representative can arrange for removal. Consignees were also asked to complete and return the attached "Fax-Back Response Form" to Biomet at 1-574-372-1683.
Further questions can be directed to Biomet Orthopedics at 1-800-348-9500.
Worldwide Distribution -- US including PR and states of AZ, AL, AR, CA, CO, FL, IL, IN, KY, KS, MA, MI, LA, NY, SD, GA, MN, PA, NJ, MD, MI, OH, ME, TX, WA, WI and VA and countries of Australia, Belgium, Canada, Costa Rica, Finland, Netherlands and South Wales.
제품 설명
Biomet Biolox-Delta Modular Ceramic Head, 28 mm head diameter, plus 5 neck, type 1, taper, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Catalog Number 12-115112. || A hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint.
“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.