Product 7 consists of all products under product code HWC, and same usage: || Item no: || 47234801435 3.5MM CORT SCR X 14MM || 47234801635 3.5MM CORT SCR X 16MM || 47234806535 3.5MM CORT SCR X 65MM || 47234807035 3.5MM CORT SCR X 70MM || 47234807535 3.5MM CORT SCR X 75MM || 47234808035 3.5MM CORT SCR X 80MM || 47234808535 3.5MM CORT SCR X 85MM || 47234809035 3.5MM CORT SCR X 90MM || Product Usage: || A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
“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.
The product was shipped to Hawaii, New York, South Carolina, and South Dakota in the United States.
제품 설명
Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets.