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.
Incorrect labeling on specific lots of the intramedullary bone saw. the saw blade assembly was identified as cam assembly.
조치
The firm, BIOMET, sent an "URGENT MEDICAL DEVICE SAFETY ALERT" letter dated February 26, 2014 via Fed Ex overnight to domestic consignees. Australia and GSCC were notified by email and also received a hard copy letter via mail. The letter described the product, problem and actions to be taken. The letter stated that this action requires the immediate location and discontinued use of the product and its return to Biomet. The Consignees were were instructed to immediately locate, discontinue use of the product and remove the identified device(s) listed; carefully follow the instructions on the FAX Back Response Form and reply within three (3) business days; complete and return Form via Fax to: 574-372-1683 prior to return of product, and use priority carrier for your shipment. If you have further distributed this product, you MUST notify hospital personnel of this action via enclosed "Dear Risk/Recall Manager Notice", and note that you are charged with the location and return of these products. Shipping address is Return Goods, 56 E. Bell Drive Warsaw, IN 46582.
Questions related to the notice should be directed to 574-372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.
제품 설명
Part 475625, Intramedullary Bone Saw, Cam Assembly || Size 13 mm, || The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
“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.