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.
In some cases it has been difficult or not possible to disassemble the adjusted dome centric from the as humeral rasp after initial positioning of the as humeral trial head which resulted in the whole construct of the dome centric with the still assembled as humeral rasp taken out of the humeral canal. this could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery, increasing the infection risk or second use of anesthesia necessary.
조치
Zimmer Biomet sent an URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notification dated May 17, 2016, to all affected consignees via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Consignees were instructed to review the notification and ensure affected personnel were aware of the contents. Assist their Zimmer Bioment sales representative with the quarantine of any affected product from the table above. Complete the Certificate of Acknowledgement Form and return to corporatequality.postmarket@zimmerbiomet.com.
If after reviewing this notification consignees have further questions or concerns please call the customer call center at 1- 800-348-2759 between 8:00 am and 8:00 pm EST.
Nationwide Distribution to AZ, CA, CO, GA, IL, KS, KY, MA, MD, MO, OH, PA, TN, and TX.
제품 설명
Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. || The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. || The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
“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.