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.
Pmma coating does not meet specifications. area of the stem may be missing pmma coating.
조치
Zimmer sent an URGENT MEDICAL DEVICE RECALL - Lot Specific letter dated February 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Your Responsibilities
1. Review the notification and ensure affected personnel are aware of the contents.
2. Locate and remove from inventory the affected products identified above.
3. Return any affected product with missing PMMA coating per the PER process
4. Return the Notification Acknowledgment Form (Attachment 1) to corporatequality.postmarket@zimmer.com.
5. Please notify Zimmer if the hospital that you have distributed the affected product to has implanted the product. In
addition, identify the surgeons that have used this product.
6. If after reviewing this notification you have further questions or concerns please call the customer call center at
1-877-946-2761 between 8:00 am and 5:00pm EST.
“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.