The Implant Files -
International Medical Devices Database
- About this investigation
- International Medical Devices Database
- Tell us your story
- Resources for patients
- Reporting partners
- Video introduction
Stories - Patients harmed by medical devices
- Europe, a device gateway to the world
- History of the industry
- The Medtronic way
- Ruptured trust and breast implants
- Heart device raises risk questions
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Model / Serial
lot no.: 61771007 61827364 61853067 61865449 61870424 61888695 61953208 62230187 61853068 61870425 61953213 62230188 61860667 61895085 61937602 61953221 62230190 62271893 61900049 61900056 61958816 62124265 62124266 62241683 62255907 61778898 61860656 61870426 61853070 61900064 370958 61777470 61834885 61934150 370957 61888707 62271892
- Product Classification
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Device Class
2
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Implanted device?
Yes
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Distribution
US Nationwide Distribution
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Product Description
Product 31 consists of all product under product code: KTT and same usage: || Item no: || 118113003 FREE-LOCK TUBE & SCP PLAT || 118113502 FREE-LOCK TUBE & SCP PLAT || 118113503 FREE-LOCK TUBE & SCP PLAT || 118114002 FREE-LOCK TUBE & SCP PLAT || 118114003 FREE-LOCK TUBE & SCP PLAT || 118114502 FREE-LOCK TUBE & SCP PLAT || 118114503 FREE-LOCK TUBE & SCP PLAT || 118115002 FREE-LOCK TUBE & SCP PLAT || 118115003 FREE-LOCK TUBE & SCP PLAT || 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.
- Manufacturer
- 1 Event
Manufacturer
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Manufacturer Address
Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
- Manufacturer Parent Company (2017)
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Manufacturer comment
“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.
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Source
USFDA
263 devices with a similar name
Learn more about the data here
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Model / Serial
- Product Classification
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Device Class
2
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Implanted device?
Yes
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Distribution
Nationwide Distribution
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Product Description
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.
- Manufacturer
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Model / Serial
All lots in distribution prior to 5/8/17
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Distribution
Nationwide Worldwide
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Product Description
Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
- Manufacturer
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Model / Serial
Lot Numbers: 63399406, 63399407, 63413258, 63418122, 63419454, 63421749, 63471169, 63471170, 63471171, 63474753, 63474754, 63484232, 63501370, 63633540, 63649266 & 63655091.
- Product Classification
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Device Class
2
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Implanted device?
Yes
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Distribution
Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
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Product Description
Zimmer Trabecular Metal(TM) Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile
- Manufacturer
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Model / Serial
Lot Numbers: 63574373, 63622721, 63398756, 63415316, 63444654, 63462301, 63474169, 63485122, 63485126, 63496894, 63505359, 63530405 & 63530406
- Product Classification
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Device Class
1
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Implanted device?
No
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Distribution
Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
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Product Description
Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7 mm Diameter, Item Number/EDI 00236015327, Nonsterile
- Manufacturer
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Model / Serial
Lot Numbers: 63584061 & 63634136
- Product Classification
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Device Class
1
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Implanted device?
No
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Distribution
Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
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Product Description
Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249004443, Nonsterile
- Manufacturer