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
Articles - 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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Modèle / numéro de série
lot no.: 61895477 62274946 61771936 61859733 61895479 62049380 62274957 62274957N 61879883 61771950 61879872 61879874 61918348 61944990 62199039 62312399 62312401 62312402 62312401N 61859738 61944992 62124572 62124572N 61941119 62296602 62233795 62312404 62312404N 61944994 62134044 61771903 62152982 61941121 61944995 62233794 62233796 62296608 61771908 62180987
- Classification du dispositif
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Classe de dispositif
2
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Dispositif implanté ?
Yes
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Distribution
US Nationwide Distribution
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Description du dispositif
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.
- Manufacturer
- 1 Event
Fabricant
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Adresse du fabricant
Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
- Société-mère du fabricant (2017)
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Commentaire du fabricant
“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 dispositifs médicaux avec un nom similaire
En savoir plus sur les données ici
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Modèle / numéro de série
Catalog Number TSVT6B13, Lot Number 62284006. 5-year expiration. January 2018.
- Classification du dispositif
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Classe de dispositif
2
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Dispositif implanté ?
Yes
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Distribution
Nationwide Distribution.
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Description du dispositif
Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
- Manufacturer
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Modèle / numéro de série
Part Number 00-2358-014-04; lot 62276042
- Classification du dispositif
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Classe de dispositif
2
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Dispositif implanté ?
Yes
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Distribution
Worldwide Distribution - US including the states of CA and OH., and the countries of BRAZIL, CHINA, KOREA and TAIWAN.
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Description du dispositif
Zimmer Periarticular Locking Plate System Distal Radial Volar Plate Lateral Column (1st generation stainless steel only). Orthopedic fixation plate. For temporary internal fixation and stabilization of osteotomies and fractures.
- Manufacturer
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Modèle / numéro de série
00-5926-014-01; Lot 62455332
- Classification du dispositif
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Classe de dispositif
2
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Dispositif implanté ?
Yes
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Distribution
Worldwide Distribution - US (nationwide) in the states of HI, CA, GA, MI, and IL and the countries of TAIWAN, BELGIUM, AUSTRALIA, FRANCE, JAPAN, and UK.
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Description du dispositif
Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.
- Manufacturer
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Modèle / numéro de série
BKL0398L 20-8070-002-01; DHA0645L 20-8070-002-01; DHA0646R 20-8070-002-02; ECO0516L 20-8070-002-01; GHE0651R 20-8070-002-02; KAD0595L 20-8070-002-01; KWI0523R 20-8070-002-02; MHA0483L 20-8070-002-01; MHA0484R 20-8070-002-02; MKE0659R 20-8070-002-02; MMA0728R 20-8070-002-02; SSC0782L 20-8070-001-01; TCA0582L 20-8070-002-01; THO0803L 20-8070-002-01; TMA0760L 20-8070-002-01; Expiration dates 5/8/14-12/31/15
- Classification du dispositif
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Classe de dispositif
2
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Dispositif implanté ?
Yes
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Distribution
US Distribution in states of: AZ, CO, IL, OR, and WA.
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Description du dispositif
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer || The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
- Manufacturer
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Modèle / numéro de série
Lot 2385941.
- Classification du dispositif
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Classe de dispositif
2
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Dispositif implanté ?
Yes
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Distribution
Maryland.
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Description du dispositif
Zimmer Anatomical Shoulder Prosthesis, Glenoid, Cemented, sterile; REF 01.04214.370.
- Manufacturer