Devices

Device Recall Zimmer

  • Modèle / numéro de série
    lot no.: 61902234 61930449 62238240 61781914 61818112 61873640 61873641 61921821 61930453 62142331 62171289 61656184 61656185 61663560 61818114 61818116 61818118 61873642 61930459 61969224 61969225 62118686 62238244 62250669 62279154 62279156 61640868 61781919 61781920 61866144 61866145 61969228 62122251 62142308 62171295 62255624 62279159 61663622 61781922 61781927 61831643 61862302 61930474 62142311 62232636 62238251 62283223 62283223N 61663623 61781928 61866147 62092290 62155425 62031720
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 14 consists of all product under product code HSB || , and same usage: || Item no: || 225600230 ASIA ONE-PIECE LAG SCREW || 225600232 ASIA ONE-PIECE LAG SCREW || 225600235 ASIA ONE-PIECE LAG SCREW || 225600237 ASIA ONE-PIECE LAG SCREW || 225600240 ASIA ONE-PIECE LAG SCREW || 225600242 ASIA ONE-PIECE LAG SCREW || 225600245 ASIA ONE-PIECE LAG SCREW || 225600227 ASIA ONE-PIECE LAG SCREW 70MM || Product Usage: || An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
  • Manufacturer
    Zimmer Manufacturing B.V.
  • 1 Event

Fabricant

Zimmer Manufacturing B.V.
  • Adresse du fabricant
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • Société-mère du fabricant (2017)
    Zimmer Biomet Holdings
  • 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.
  • Source
    USFDA

263 dispositifs médicaux avec un nom similaire

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Device Recall Zimmer MIS
  • Modèle / numéro de série
    Lots 60244776, 60254445, 60270467, 60278638, 60298344, 60317739, 60330363 and 60342788.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Lots 60244777, 60254446, 60259343, 60280558, 60295662, 60298480, 60307612, 60333170 and 60336853.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Lots 08686700 and 08686500.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Lots 08686600 and 08686800.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, Australia, Canada, Germany, Korea, Singapore and Taiwan.
  • Description du dispositif
    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
  • Modèle / numéro de série
    Lots 14865700, 17308800, 17733600, 17733700, 19001400, 24543400 and 25105000.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.
  • Description du dispositif
    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.
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