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.
데이터 추가 비고
Implant, endosseous, root-form - Product Code DZE
원인
A single lot of product that potentially has a single part within the lot that does not match the product on the label due to a commingle at the firm supplier.
조치
On March 13 Zimmer Biomet contacted their international consignee and asked them to:
1. Review this notification and ensure affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1 Inventory Return Certification Form. a. Return a digital copy to postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship within your territory along with a completed Attachment 1 Inventory Return Certification Form to Biomet 3i.
a. For each return, send a copy of Attachment 1 to postmarket@zimmerbiomet.com.
b. Include a hardcopy of Attachment 1 with your shipment for immediate processing. c. Mark the outside of the returns box(es) clearly with RECALL.
5. Retain a copy of your recall acknowledgement and product return forms for your records in the event of a compliance audit of your facility.
If after reviewing this notice you have further questions or concerns please contact us by email at postmarket@zimmerbiomet.com.
1-800-342-5454
“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.