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
Screwdriver - Product Code HXX
원인
Increased risk of failure at the driver tip during screw insertion or removal.
조치
Biomet Spine sent a "Urgent Medical Device Recall" notices dated February 6, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to immediately locate and remove affected items from circulation and return affected product to EBI, LLC.
Please follow the instructions on the enclosed "FAX Back Response Form, "
and fax a copy of the Response Form to (973) 257-0232, prior to return of the items.
Questions related to this notice should be directed to (973) 299-9300 ex. 2322.
Monday through Friday, 8am to 5pm.
Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.
제품 설명
Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
“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.