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
none - Product Code NDG
원인
Zimmer recently conducted a review of historic packaging validations completed. based on this review, it was determined that a subset of product packaged at a single zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. the number of samples required for packaging testing, to provide statisti.
조치
The firm, Zimmer Inc., sent a letter entitled "Voluntary Recall of Ti-VFxII Condylar Tube Plates and Ti-Washers" dated September 12, 2013 to its customer. The letter described the product, problem and action to be taken. The customer was instructed to immediately discontinue use of the listed products. A Sales representatives from Zimmer K.K. or agencies will be in contact with you. Zimmer Inc. is planning to resume product manufacturing upon the completion of package validation review. Zimmer K.K. will contact you when a detailed schedule has been determined.
If you have any questions, contact Zimmer K.K. Safety Office (9:00 to 17:00; closed weekends and public holidays) TEL: 0120-015-180.
Ti-Magna Fx Washer || Ti-Versa-FX¿II Femoral Fixation System S/C Plates || The compression tube/plates of this trauma system are used with Ti-Versa-Fx¿ II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna Fx System is an osteosynthesis item for orthopedic use in open internal fixation of fractures of the femoral neck, condyle, or tibia, etc. The washer prevents the screw head from being buried in the bone.
“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.