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
Appliance, fixation, spinal intervertebral body - Product Code KWQ
원인
Some of p/n 14-521614b lot 375440 was mislabeled as p/n 14-521614 lot 375440.
조치
Zimmer Biomet sent an Urgent Medical Device Recall Notice dated August 5, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by customer. Customers were instructed to immediately locate and discontinue use of the affected product.
This action requires the immediate location and discontinued use of the item
and its immediate return to Zimmer Biomet Spine. Specifically, customers were REQUIRED to take the following steps:
" Immediately locate and remove from circulation the items consigned/loaned to your
account as identified on page two of this notice.
" Carefully follow the instructions on the enclosed "Response Form".
" If you have further distributed these items to medical facilities, you MUST notify them of this action. This letter MUST be given to the person responsible for receiving recall notices. However, you are charged with the location and return of these items.
Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone:
Online:
Fax:
Phone:
Regular Mail:
www. fda .gov /MedWatch/report.htm
(800) FDA-0178
(800} FDA-1088
Use postage-paid FDA form 3500 available at www.fda.gov/Medwatch/getforms.htm
and mail to Medwatch, 5600 Fishers Lane, Rockville, MD 20852-9787.
Questions related to this notice should be directed to 303-501-8400 Monday through Friday, 8 a.m.to 5 p.m. MST.
Zimmer Blomet
“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.