Devices

Device Recall Zimmer

  • Modèle / numéro de série
    lot no.61951256 62230459 61907760 61907764 61926199 62261661 61926201 61907767 61907769 61907771 61909381 62230462 61907772 61196133 61907773 62020888 61920808
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Product 4 consists of all products under product code HWC, and same usage: || Item no: || 47482002603 2.0 X 26 CORT SCREW CRUCI || 47482002803 2.0 X 28 CORT SCREW CRUCI || 47482003203 2.0 X 32 CORT SCREW CRUCI || 47482003403 2.0 X 34 CORT SCREW CRUCI || 47482003603 2.0 X 36 CORT SCREW CRUCI || 47482003803 2.0 X 38 CORT SCREW CRUCI || 47482004003 2.0 X 40 CORT SCREW CRUCI || 47482004203 2.0 X 42 CORT SCREW CRUCI || 47482004403 2.0 X 44 CORT SCREW CRUCI || 47482004603 2.0 X 46 CORT SCREW CRUCI || 47482004803 2.0 X 48 CORT SCREW CRUCI || 47482005003 2.0 X 50 CORT SCREW CRUCI || 47482702000 2.7 X 20 CORT SCREW HEX || Product 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

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

En savoir plus sur les données ici

Device Recall Zimmer Periarticular Locking Plate System
  • Modèle / numéro de série
    Lot Numbers: 63574373, 63622721, 63398756, 63415316, 63444654, 63462301, 63474169, 63485122, 63485126, 63496894, 63505359, 63530405 & 63530406
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Description du dispositif
    Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7 mm Diameter, Item Number/EDI 00236015327, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall Zimmer Natural Nail System Calibrated Drill Long
  • Modèle / numéro de série
    Lot Numbers: 63584061 & 63634136
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Description du dispositif
    Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249004443, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall Zimmer Periarticular Locking Plate System
  • Modèle / numéro de série
    Lot Numbers: 63578494, 63641443 & 63524035.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Description du dispositif
    Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI 00236015335, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall Zimmer Periarticular Locking Plate System
  • Modèle / numéro de série
    Lot Numbers: 63545430, 63578497, 63586028, 63606286, 63610624, 63635345, 63458048, 63469766, 63475222 & 63530224.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Description du dispositif
    Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Connect 2.7 mm O.D., Item Number/EDI 00236017127, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
Device Recall Zimmer Periarticular Locking Plate System Drill
  • Modèle / numéro de série
    Lot Numbers: 63599481, 63461425, 63469758, 63469758, 63475225 & 63481881.
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.
  • Description du dispositif
    Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Item Number/EDI 00236017520, Nonsterile
  • Manufacturer
    Zimmer Biomet, Inc.
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