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 recently conducted a review of all historic packaging validations at its zimmer manufacturing b.V. (zmbv) facility in ponce, puerto rico. based on this review, it was determined that the packaging operations conducted in the building 1 packaging operation at this facility were not properly validated. as a result, zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. the acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. these packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the zmbv facility building 1 packaging operations.
조치
Distributors received a letter identifying the issue and their responsibilities dated November 4, 2013. These responsibilities include quarantining the affected fielded inventory in their possession, providing hospital risk managers with the recall notification letter and retrieving affected fielded inventory and direct sales from the hospitals.
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
제품 설명
MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID
“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.