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
Prosthesis, hip, femoral component, cemented, metal - Product Code JDG
원인
Zimmer is initiating a voluntary recall of 20 production lots of moore hip prosthesis long fenestrated stems due to packaging design verification test failures. specifically, 9 of 16 test samples failed simulated distribution and shipping testing when the moore hip stem breached either the inner or outer package tray. zimmer has not received any complaints of damaged package trays for these 20 lot.
조치
On July 1, 2014 Zimmer, Inc. issued recall notification to their consignees via letter. This notice was issued to affected distributors and hospitals with instructions for returning the affected product. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory, as well as identifying hospitals and surgeons who have previously implanted the affected product and providing related contact information (name, address, and phone number). Distributors are to return on-hand affected products to Zimmer and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product and returning it to their Zimmer sales representative.
Part 00402100838, Lot 62435853; Part 00402100841, Lot 62435854; Part 00402100843, Lot 62396506; Part 00402100844, Lot 62424468; Part 00402100848, Lot 62435852; Part 00402100848, Lot 62467218; Part 00402100848, Lot 62511381; Part 00402100851, 37108214; Part 00402100852, Lot 62511377; Part 00402100854, Lot 62511379; Part 00402101241, Lot 62352570; Part 00402101244, Lot 62424469; Part 00402101246, Lot 62400669; Part 00402101248, Lot 62400670; Part 00402101249, Lot 62467222; Part 00402101251, Lot 62470576; Part 00402101252, Lot 62435851; Part 00402101254, Lot 62424470; Part 00402101257, Lot 62524114; & Part 00402101260, Lot 62524115.
Worldwide Distribution - US (nationwide) in the states of IN, WI, MN, OR, and TX, and one foreign consignee in Canada.
제품 설명
Moore Hip Prosthesis Long Fenestrated Stem 38 mm (1-1/2 Inch) Head Diameter 203 mm Length. || Product Usage: || The Moore Hip Prosthesis is a femoral him stem that can be used where there is roentgenogrpahic evidence of a satisfactory actabulum and sufficient bone in the femoral neck to seat the prosthesis with or without bone cement.
“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.