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.
Components of the dvr epaks can oxidize during shipment and storage prior to use. a delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-sterilize the product.
if oxidative material would flake off a component contained within the epak and enter the surgical field/wound an inflammatory reaction may occur. the inflammatory reaction may result in a foreign body reaction and/or metal hypersensitivity. oxidized components have failed cytotoxicity testing.
조치
The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated 1/29/2016 to the affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The customers were instructed to immediately locate and remove the identified device(s); carefully follow instructions on enclosed Response Form; complete and return Response Form within three (3) business days via email to CPWARFieldAction@zimmerbiomet.com prior to return of product, use priority carrier for your shipment; if you have further distributed the product, you MUST notify hospital personnel of this action.
Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Worldwide distribution: US (Nationwide) and countries of: Panama; Korea; Japan; Netherlands; Ecuador; Chile; Canada; and Australia.
제품 설명
Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation || The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic 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.