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
관련기사 - 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
-
모델명 / 제조번호(시리얼번호)
lot no.: 61555543 61597965 61670825 62079145 62079148 62124066 62135039 62185960 62203621 62221041 62221043 62221044 62267947 62267949 62267950 62268526 62277492 62277493 62278701 62278702 62278703 62340123 62397828 62397831 62267950N 62278701N 62278702N 62278703N 61597959 61653581 62218170 62265345 62277494 62294359 62218170N 62277494N 62294359N 61292730N 62122127 62267951 62267952 62278704 62267952N 62278704N 62181482 62304835 62304835N 62203622 62203622N 62289044 62391711 62289044N 62391711V 61854615 61977887 62135046 62162460 62267946 62268527 62340121 62268527N 62289054 62289083 62304837 62289054N 62289083N 62304837N
- 의료기기 분류등급
-
의료기기 등급
2
-
이식된 장치?
Yes
-
유통
US Nationwide Distribution
-
제품 설명
Product 26 consists of all product under product code: JWH and same usage: || Item no: || 234703104 DISTAL MEDIAL FEMORAL CON || 234703206 DISTAL MEDIAL FEMORAL CON || 234703208 DISTAL MEDIAL FEMORAL CON || 234800504 DISTAL POSTERIOR/LATERAL || 234800506 DISTAL POSTERIOR/LATERAL || 234800508 DISTAL POSTERIOR/LATERAL || 234800510 DISTAL POSTERIOR/LATERAL || 234800604 DISTAL POSTERIOR/LATERAL || 234800606 DISTAL POSTERIOR/LATERAL || 234800608 DISTAL POSTERIOR/LATERAL || 234800610 DISTAL POSTERIOR/LATERAL || 234800614 DISTAL POSTERIOR/LATERAL || Product Usage: || For use in total or hemi hip arthroplasty
- Manufacturer
- 1 Event
제조사
-
제조사 주소
Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
- 제조사 모회사 (2017)
-
제조사 의견
“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.
-
Source
USFDA
유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 263 건
데이터에 대해 더 자세히 알아보기 여기
-
모델명 / 제조번호(시리얼번호)
Lots P050120 and P041466.
- 의료기기 분류등급
-
의료기기 등급
1
-
이식된 장치?
No
-
유통
Worldwide Distribution --- USA including states of California, Minnesota, Ohio, Pennsylvania, and Tennessee, and countries of Denmark, Germany, Iran, Italy, Russia, Singapore, Spain, Switzerland, and United Kingdom.
-
제품 설명
Zimmer Silhouette Axial Torque Handle, Zimmer Spine, Inc., Minneapolis, MN; REF 7010-0151-01. || Reusable instrument that is used to apply the appropriate torque to the lock nut that is part of the Silhouette Spinal Fixation System.
- Manufacturer
-
모델명 / 제조번호(시리얼번호)
Lot Numbers: 08701500, 60244766, 60254447, 60277967, 60289960, 60293969, 60313973, 60321519, 60331048, 60353723, 60360727, 60380526, 60406615, 60407562, 60422090, 60423663, 60454975, 60517608, 60685054, 60812396 and 60813212.
- 의료기기 분류등급
-
의료기기 등급
1
-
이식된 장치?
No
-
유통
Worldwide Distribution --- including USA, Belgium, Czech Republic, Finland, Germany, Greece, Italy, Poland, Romania, Spain and United Kingdom.
-
제품 설명
Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 30 degrees, Zimmer, Warsaw, IN; REF 00-7806-035-01. || The offset rasp handle is a surgical instrument used with various sizes of femoral rasps to prepare the femoral canal for a hip implant.
- Manufacturer
-
모델명 / 제조번호(시리얼번호)
Lots 60969810 and 60969811.
- 의료기기 분류등급
-
의료기기 등급
1
-
이식된 장치?
No
-
유통
Nationwide, Canada, Denmark, Finland, Germany, Poland, Spain, Sweden and United Kingdom.
-
제품 설명
Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 14 MM Height, nonsterile, Zimmer, Warsaw, IN; REF 5971-50-14. || Used during total knee arthroplasty surgery to determine the required thickness of the tibial bearing surface to be implanted. Reusable, non-implantable.
- Manufacturer
-
모델명 / 제조번호(시리얼번호)
Lots 61007188, 60987590, 60969807, 60976981 and 60976982.
- 의료기기 분류등급
-
의료기기 등급
1
-
이식된 장치?
No
-
유통
Nationwide, Canada, Denmark, Finland, Germany, Poland, Spain, Sweden and United Kingdom.
-
제품 설명
Zimmer NEXGEN Complete Knee Solution Cruciate Retaining (CR) Provisional - Articular surface, Size Blue, 12 MM Height, nonsterile, Zimmer, Warsaw, IN; REF 5971-50-12. || Used during total knee arthroplasty surgery to determine the required thickness of the tibial bearing surface to be implanted. Reusable, non-implantable.
- Manufacturer
-
모델명 / 제조번호(시리얼번호)
Lot 60830979.
- 의료기기 분류등급
-
의료기기 등급
2
-
이식된 장치?
Yes
-
유통
Nationwide Distribution --- including states of Arkansas, Florida, Michigan, North Carolina, New York and Wisconsin.
-
제품 설명
Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate, Right, Size 3, For cemented use only, sterile, Zimmer, Warsaw, IN; REF 6420-01-230. || The modular cemented tibial baseplate is indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. || These are single use implantable devices sold sterile.
- Manufacturer