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
Template - Product Code HWT
원인
Complaints have been received reporting sub-optimal fit between provisional femoral heads (versys and mis) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. intraoperative dislodging of the provisional head and the provisional head being left in-vivo after separating from mating comp.
조치
Zimmer, Inc. sent an E-mail letter dated April 21, 2011, to all affected customers in the US. A June 2011 E-mail was sent to all customers outside the US. The letters requested Inventory & Operations Managers to check product for proper fit /function, complete the return form with worn provisional heads to Zimmer Inc, Attention Product Service, 1777 West Center St. Warsaw, IN 46580.
For questions regarding this recall call 574-372-4753.
Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.
제품 설명
12/14 Neck Taper || 00789504001 VerSys Femoral Head Provisional 40mm -3.5 || 00789504002 VerSys Femoral Head Provisional 40mm +0 || 00789504003 VerSys Femoral Head Provisional 40mm +3.5 || 00789504004 VerSys Femoral Head Provisional 40mm +7 || 00789504005 VerSys Femoral Head Provisional 40mm +10.5 || The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.
“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.