Product 41 consists of all product under product code: KTT and same usage: || Item no: || 119301042 LAG SCR 12.7D X 100MM STA || 119301045 LAG SCR 12.7D X 105MM STA || 119301047 LAG SCR 12.7D X 110MM STA || 119301050 LAG SCR 12.7D X 115MM STA || 119301052 LAG SCR 12.7D X 120MM STA || 119301055 LAG SCR 12.7D X 125MM STA || 119301057 LAG SCR 12.7D X 130MM STA || 119301060 LAG SCR 12.7D X 135MM STA || 119301062 LAG SCR 12.7D X 140MM STA || 119301070 LAG SCR 12.7D X 155MM STA || 119301020 LAG SCR 12.7D X 55MM STAN || 119301022 LAG SCR 12.7D X 60MM STAN || 119301025 LAG SCR 12.7D X 65MM STAN || 119301027 LAG SCR 12.7D X 70MM STAN || 119301030 LAG SCR 12.7D X 75MM STAN || 119301032 LAG SCR 12.7D X 80MM STAN || 119301035 LAG SCR 12.7D X 85MM STAN || 119300537 LAG SCR 12.7D X 90MM SHOR || 119301037 LAG SCR 12.7D X 90MM STAN || 119301040 LAG SCR 12.7D X 95MM STAN || 119301542 LAG SCR 15.8D X 100MM LAR || 119301545 LAG SCR 15.8D X 105MM LAR || 119301547 LAG SCR 15.8D X 110MM LAR || 119301550 LAG SCR 15.8D X 115MM LAR || 119301552 LAG SCR 15.8D X 120MM LAR || 119301555 LAG SCR 15.8D X 125MM LAR || 119301557 LAG SCR 15.8D X 130MM LAR || 119301520 LAG SCR 15.8D X 55MM LARG || 119301522 LAG SCR 15.8D X 60MM LARG || 119301525 LAG SCR 15.8D X 65MM LARG || 119301532 LAG SCR 15.8D X 80MM LARG || 119301535 LAG SCR 15.8D X 85MM LARG || 119301537 LAG SCR 15.8D X 90MM LARG || Product Usage: || Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached 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.
Lot # 61977101, Serial # 500001 500019 Lot # 61980678, Serial # 500021 500040 Lot # 61989398, Serial # 500081 500090 Lot # 62008619, Serial # 500091 500110 Lot # 62083340, Serial # 500151 500170 Lot # 62096333, Serial # 500171 500190 Lot # 62122378, Serial # 500191 500210 Lot # 62191658, Serial # 500211 500230 Lot # 62191665, Serial # 500231 500250 Lot # 62220857, Serial # 500251 500270 Lot # 62220882, Serial # 500291 500310 Lot # 62244236, Serial # 500331 500350 Lot # 62266024, Serial # 500351 500371 Lot # 62267510, Serial # 500372 500391 Lot # 62267596, Serial # 500452 500471 Lot # 62289834, Serial # 500412 500431 Lot # 62309628, Serial # 500472 500491 Lot # 62309698, Serial # 500512 500531 Lot # 62369392, Serial # 500532 500551 Lot # 62374685, Serial # 500552 500571 Lot # 62374721, Serial # 500592 500611 Lot # 62393971, Serial # 500632 500651 Lot # 62394012, Serial # 500652 500671 Lot # 62454338, Serial # 500692 500711 Lot # 62476761, Serial # 500712 500731 Lot # 62494048, Serial # 500732 500751 Lot # 62494086, Serial # 500752 500771 Lot # 62525837, Serial # 500772 500791 Lot # 62554526, Serial # 500792 500811 Lot # 62578715, Serial # 500812 500831 Lot # 62578759, Serial # 500832 500851 Lot # 62635778, Serial # 500852 500871
US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.
Description du dispositif
Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. || The Zimmer Air Dermatome II handpiece and width plates are packaged inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope. || The Zimmer Air Dermatome II is a skin grafting instrument that is intended to provide variable graft thickness and width capabilities.
There are no lot code(s) for the 01-8851-001-00 loaner part number due to when the device is physically manufactured, it is done so as part number 00-8851-001-00 and lot codes are assigned to this part number. The 01-8851-001-00 exists in order to differentiate that the device is being distributed as a loaner rather than a sale of the device
US Nationwide Distribution including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, and WI.
Description du dispositif
Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device is packaged inside of a padded-foam corrugate box. A product label is applied to the lid of the box. The width plates, when sold individually, are placed in a labeled poly zipper bag, which is then placed into a corrugated shipper carton or padded envelope.
The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior surfaces of the device are textured to provide increased stability and convex to conform to the vertebral endplates. The device also has two slots on the posterior end to mate with the insertion instrument. The TM Ardis device is wholly comprised of Trabecular Metal Porous Tantalum. Surgical instrumentation for use with the proposed system will be fabricated from surgical grade stainless steel and other applicable materials.
Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
Description du dispositif
Zimmer Trabecular Metal(TM) Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile