Devices

Device Recall Zimmer

  • 모델명 / 제조번호(시리얼번호)
    lot no.: 62127759 62196525 61955423 62289877 62052696 62052696N 62144719 61930078 62138079 62052697 61960862 62253596 62253596N 62027415 62052698 62052699 61567438 61966260 61966261 61966262 61966263 61966264 61966265 61641810 61903337 61903338 61898112 62138080 61903334 61903335 61903336 61966254
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 56 consists of all product under product code: HWC and same usage: || Item no: || 47234702032 PERI SCR 3.5MM X 32MM STE || 47234702018 PERI SCR. 3.5MM X 18MM ST || 47234702020 PERI SCR. 3.5MM X 20MM ST || 47234702022 PERI SCR. 3.5MM X 22MM ST || 47234702026 PERI SCR. 3.5MM X 26MM ST || 47234702030 PERI SCR. 3.5MM X 30MM ST || 47234702034 PERI SCR. 3.5MM X 34MM ST || 47234702036 PERI SCR. 3.5MM X 36MM ST || 47234702042 PERI SCR. 3.5MM X 42MM ST || 47234702046 PERI SCR. 3.5MM X 46MM ST || 47234702050 PERI SCR. 3.5MM X 50MM ST || 47234702080 PERI SCR. 3.5MM X 80MM ST || 47234702085 PERI SCR. 3.5MM X 85MM ST || 47234702155 PERI SCR. 4.0MM X 55MM || 47234702160 PERI SCR. 4.0MM X 60MM || 47234702210 PERI SCR. 4.0MMX10MM FULL || 47234702212 PERI SCR. 4.0MMX12MM FULL || 47234702214 PERI SCR. 4.0MMX14MM FULL || 47234702216 PERI SCR. 4.0MMX16MM FULL || 47234702260 PERI SCR. 4.0MMX60MM FULL || 47234702336 PERI SCR. 4.5MM X 36MM || 47234702338 PERI SCR. 4.5MM X 38MM || 47234712440 PERI SCR. 6.5MM X 140MM || 47234702670 PERI SCR. 6.5MM X 70MM || 47234702122 PERI. SCR 4.0MM X22MM || 47234702124 PERI. SCR 4.0MM X24MM || 47234702126 PERI. SCR 4.0MM X26MM || 47234702128 PERI. SCR 4.0MM X28MM || Usage: || A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
  • Manufacturer
    Zimmer Manufacturing B.V.
  • 1 Event

제조사

Zimmer Manufacturing B.V.
  • 제조사 주소
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 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

Device Recall Zimmer MIS
  • 모델명 / 제조번호(시리얼번호)
    Lots 60244776, 60254445, 60270467, 60278638, 60298344, 60317739, 60330363 and 60342788.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • 제품 설명
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Left, 45 degrees, non-sterile; Part number 00-7712-035-01.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer MIS
  • 모델명 / 제조번호(시리얼번호)
    Lots 60244777, 60254446, 60259343, 60280558, 60295662, 60298480, 60307612, 60333170 and 60336853.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • 제품 설명
    Zimmer Minimally Invasive Solutions Technology Offset Rasp Handle, Right, 45 degrees, non-sterile; Part number 00-7712-035-02.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer M/L
  • 모델명 / 제조번호(시리얼번호)
    Lots 08686700 and 08686500.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • 제품 설명
    Zimmer M/L Taper Rasp Handle, Left, 45 degrees, non-sterile; Part number 83-7712-035-01. Recall Z-0671-06 extended to include this product.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer M/L
  • 모델명 / 제조번호(시리얼번호)
    Lots 08686600 and 08686800.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • 제품 설명
    Zimmer M/L Taper Rasp Handle, Right, 45 degrees, non-sterile; Part number 83-7712-035-02. Recall Z-0671-06 extended to include this product.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer M/DN Intramedullary Fixation
  • 모델명 / 제조번호(시리얼번호)
    Lots 14865700, 17308800, 17733600, 17733700, 19001400, 24543400 and 25105000.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.
  • 제품 설명
    Zimmer M/DN Intramedullary Fixation 4.2 dia. cortical screw, 3.5 mm hex head, 75 mm length, 22-13-5 stainless steel, sterile bone screw; Cat. no. 2253-75-42 (00225307542).
  • Manufacturer
    Zimmer Inc.
하나 더 258 건 더