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
Historias - 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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Modelo / Serial
- Clasificación del producto
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Clase de dispositivo
2
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¿Implante?
Yes
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Distribución
US Nationwide Distribution
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Descripción del producto
Product 53 consists of all product under: product code: JWH and same usage: || Item no: || 597002501 NEXGEN PRECOAT PEG TIB PL || 597002502 NEXGEN PRECOAT PEG TIB PL || 597003501 NEXGEN PRECOAT PEG TIB PL || 597003502 NEXGEN PRECOAT PEG TIB PL || 597004501 NEXGEN PRECOAT PEG TIB PL || 597004502 NEXGEN PRECOAT PEG TIB PL || 597005501 NEXGEN PRECOAT PEG TIB PL || 597005502 NEXGEN PRECOAT PEG TIB PL || 597005503 NEXGEN PRECOAT PEG TIB PL || 597005504 NEXGEN PRECOAT PEG TIB PL || 598002701 NEXGEN PRECOAT STEMMED TI || 598002702 NEXGEN PRECOAT STEMMED TI || 598003701 NEXGEN PRECOAT STEMMED TI || 598003702 NEXGEN PRECOAT STEMMED TI || 598004701 NEXGEN PRECOAT STEMMED TI || 598004702 NEXGEN PRECOAT STEMMED TI || 598005701 NEXGEN PRECOAT STEMMED TI || 598005702 NEXGEN PRECOAT STEMMED TI || 598005703 NEXGEN PRECOAT STEMMED TI || 598005704 NEXGEN PRECOAT STEMMED TI || 598801510 NEXGEN SHARP FLUTED STEM || 598801511 NEXGEN SHARP FLUTED STEM || 598801512 NEXGEN SHARP FLUTED STEM || 598801513 NEXGEN SHARP FLUTED STEM || 598801514 NEXGEN SHARP FLUTED STEM || 598801515 NEXGEN SHARP FLUTED STEM || 598801516 NEXGEN SHARP FLUTED STEM || 598801517 NEXGEN SHARP FLUTED STEM || 598801518 NEXGEN SHARP FLUTED STEM || 598801519 NEXGEN SHARP FLUTED STEM || 598801520 NEXGEN SHARP FLUTED STEM || 598801010 NEXGEN STRAIGHT STEM EXT || 598801011 NEXGEN STRAIGHT STEM EXT || 598801012 NEXGEN STRAIGHT STEM EXT || 598801013 NEXGEN STRAIGHT STEM EXT || 598801014 NEXGEN STRAIGHT STEM EXT || 598801015 NEXGEN STRAIGHT STEM EXT || 598801016 NEXGEN STRAIGHT STEM EXT || 598801017 NEXGEN STRAIGHT STEM EXT || 598801018 NEXGEN STRAIGHT STEM EXT || 598801020 NEXGEN STRAIGHT STEM EXT || 598801022 NEXGEN STRAIGHT STEM EXT || 598801024 NEXGEN STRAIGHT STEM EXT || 598801112 NEXGEN STRAIGHT STEM EXT || 598801113 NEXGEN STRAIGHT STEM EXT || 598801114 NEXGEN STRAIGHT STEM EXT || 598801115 NEXGEN STRAIGHT STEM EXT || 598801116 NEXGEN STRAIGHT STEM EXT || 598801117 NEXGEN STRAIGHT STEM EXT || 598801118 NEXGEN STRAIGHT STEM EXT || 598801212 NEXGEN STRAIGHT STEM EXT || 598801215 NEXGEN STRAIGHT STEM EXT || for use in total knee arthroplasty
- Manufacturer
- 1 Event
Fabricante
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Dirección del fabricante
Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
- Empresa matriz del fabricante (2017)
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Comentario del fabricante
“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 dispositivos con un nombre similar
Más información acerca de la data acá
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Modelo / Serial
lot # 60869302 and lot # 60963801
- Clasificación del producto
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Clase de dispositivo
1
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¿Implante?
No
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Distribución
Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
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Descripción del producto
Zimmer Reconstruction System Tenaculum Left Tine Straight 9 inch, Item # 00-1179-021-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
- Manufacturer
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Modelo / Serial
lot #'s: 60544910, 60750863 and 60902482
- Clasificación del producto
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Clase de dispositivo
1
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¿Implante?
No
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Distribución
Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
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Descripción del producto
Zimmer Reconstruction System Tenaculum Right Tine Straight 9 inch, Item # 00-1179-022-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
- Manufacturer
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Modelo / Serial
lot #'s: 60806992 and 60921166
- Clasificación del producto
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Clase de dispositivo
1
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¿Implante?
No
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Distribución
Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
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Descripción del producto
Zimmer Reconstruction System Tenaculum Straight Tine Straight 9 inch, Item # 00-1179-023-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
- Manufacturer
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Modelo / Serial
lot #'s: 60636760, 60723667 and 60896770.
- Clasificación del producto
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Clase de dispositivo
1
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¿Implante?
No
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Distribución
Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
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Descripción del producto
Zimmer Reconstruction System Tenaculum 9 inch Length, One 3.5 mm Screw Tine, Item # 00-1179-024-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
- Manufacturer
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Modelo / Serial
lot #'s: 60530181, 60587803, 60739782, 60826082, and 60963803.
- Clasificación del producto
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Clase de dispositivo
1
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¿Implante?
No
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Distribución
Worldwide Distribution - USA including AL, FL, HI, IA, IL, KS KY, LA, MI, MO, MS, NC, ND, NJ, OH, OK, OR, PA, TN, TX, UT, VA, WA, AND WI and the countries of Australia, Canada, Central or South America, China, Germany, India, Italy, Saudi Arabia, and UK,
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Descripción del producto
Zimmer Reconstruction System Tenaculum Standard 9 inch, Item # 00-1179-025-00, Zimmer Inc., Warsaw, IN. || Intended to temporarily reduce pelvic fractures for fixation during reconstructive surgery.
- Manufacturer