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
Starter, bone screw - Product Code HWD
원인
One lot of 30 mm screws was switched with one lot of 25 mm screws.
조치
Biomet Orthopedics sent an Urgent Medical Device Recall Notice letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to locate and remove the affected lots from their inventory, and return them to Biomet.
Complete and enclosed FAX Back Response Form to 574-372-1683 prior to return of product.
Distributors were instructed to notify all sub-accounts of the recall.
Confirm receipt of notice by calling, 800-348-9500, extension 3755 or 3983.
For questions regarding this recall call 574-372-3983, Monday through Friday, 8AM to 5PM.
Worldwide Distribution - USA including CA, GA, IA, IL, IN, KS, KY, MD, MI, MN, MO, NC, ND, NJ, NY, OK, PA, SD, TX, VA, WA, and WI and the country of Japan.
제품 설명
Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East Bell Drive, P.O. Box 587, Warsaw, IN 46581 USA. STERILE. || To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures.
“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.