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
Reamer - Product Code HTO
원인
Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.
조치
The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated November 1, 2012 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately locate, discontinue use of and remove the product from circulation; and return recalled devices with directions to distribute notices, if product was further distributed; and to complete and return the enclosed FAX Back Response Form within three (3) business days to FAX # 574-372-1683. Distributors were charged with locating and returning products to Biomet ATTN: Return Goods-Building B RECALLS RGA#: _, Biomet, Inc., 56 East Bell Drive, Warsaw, IN 46580.
Questions should be directed to the Field Action Coordinator at (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m
Worldwide distribution: USA (nationwide) and countries of: Japan and Netherlands.
제품 설명
OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL || The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.
“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.