Product 58 consists of all product under product code: HRS and same usage: || Item no: || 234800904 PROXIMAL DORSAL ULNA PLT || 234800906 PROXIMAL DORSAL ULNA PLT || 234800908 PROXIMAL DORSAL ULNA PLT || 234800910 PROXIMAL DORSAL ULNA PLT || 234801004 PROXIMAL DORSAL ULNA PLT || 234801006 PROXIMAL DORSAL ULNA PLT || 234801008 PROXIMAL DORSAL ULNA PLT || 234801010 PROXIMAL DORSAL ULNA PLT 10H LT || 234701304 PROXIMAL MEDIAL TIBIAL 4. || 234701306 PROXIMAL MEDIAL TIBIAL 4. || 234701308 PROXIMAL MEDIAL TIBIAL 4. || 234701404 PROXIMAL MEDIAL TIBIAL 4. || 234701406 PROXIMAL MEDIAL TIBIAL 4. || 234701408 PROXIMAL MEDIAL TIBIAL 4. || 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