Devices

Device Recall Zimmer

  • Model / Serial
    lot no.: 61661156 61966578 62225735 61873650 61962858 62137227 62137228 62240762 62340060 62340060N 61820823 61881193 61957419 61962855 62172047 62175238 62234460 62262787 62291935 62298291 62298292 62310454 62314656 62340058 62298291N 62310454N 62314656N 62340058N 61878467 61881194 61883397 61886939 61899754 61968010 62221008 62284504 62285272 62291937 62291937N 61822322 62032180 62260128 62304808 62340062 62358896 62304808N 62340062N 61813932 61820819 61980168 62205493 62240263 62240771 62240772 62240773 62240774 62282932 62291138 62291938 62296576 62299089 62340063 62296576N 62340063N 61866252 62257147 62303509 62340064 62340064N 61814493 61976178 62046502 62240775 62312492 61679898 61995953 61995956 61995957 61995958 61885901 62046499 62211984 370462 61980171
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Product 70 consists of all product under product code: JDI and same usage: || Item no: || 785701000 VERSYS HERITAGE FEM STEM || 785701100 VERSYS HERITAGE FEM STEM || 785701200 VERSYS HERITAGE FEM STEM || 785701300 VERSYS HERITAGE FEM STEM || 785701320 VERSYS HERITAGE FEM STEM || 785701400 VERSYS HERITAGE FEM STEM || 785701420 VERSYS HERITAGE FEM STEM || 785701500 VERSYS HERITAGE FEM STEM || 785701520 VERSYS HERITAGE FEM STEM || 785701600 VERSYS HERITAGE FEM STEM || 785701700 VERSYS HERITAGE FEM STEM || For use in total or hemi hip arthroplasty
  • Manufacturer
    Zimmer Manufacturing B.V.
  • 1 Event

Manufacturer

Zimmer Manufacturing B.V.
  • Manufacturer Address
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “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 devices with a similar name

Learn more about the data here

Device Recall Zimmer Hemovac Wound Drainage Device Infection Control Kits
  • Model / Serial
    Lot Numbers: 60009294, 60075254, 60101562, 60156041, 60215686, 60271994, 60314032, 60389073, 60440024, 60506573 and 60590575.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.
  • Product Description
    Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number/REF: 00-2550-001-10, 400 ml INF. Cntrl. Kit w/ 3/32" drain, 2.4 mm, 7Fr, PVC, 107 cm, small, sterile, latex free, Rx only; Sold in packages of 10, which contain packages of 1 and 5; Zimmer U.K. Ltd., Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer H.A.S. Autotransfusion System H.A.S. Kit with 1/8" Drain
  • Model / Serial
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • Product Description
    Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/8" Drain , 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-020-05.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer H.A.S. Autotransfusion System H.A.S. Kit with 3/16" Drain
  • Model / Serial
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • Product Description
    Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 3/16" || Soft Drain , 4,8mm, 15Fr, PVC, 107cm, firm, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-030-05.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer H.A.S. Autotransfusion System H.A.S. Kit with 1/4" Drain
  • Model / Serial
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • Product Description
    Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/4" Drain, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-040-05.
  • Manufacturer
    Zimmer Inc.
Device Recall Zimmer H.A.S. Autotransfusion System Replacement Kit
  • Model / Serial
    All lots manufactured on or before 1/18/08. Product has a 5 year expiration period.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Australia, Canada, Chile, China, Czech Republic, Dubai, Ecuador, France, Germany, Greece, Hungary, Italy, Japan, Korea, Poland, Romania, Russia, Saudi Arabia, Serbia & Montenegro, Singapore, Slovakia, South Africa, Spain, and Switzerland.
  • Product Description
    Zimmer H.A.S. Autotransfusion System, H.A.S. Replacement Kit, sterile, latex free, Rx only; Zimmer, Swindon, Wiltshire, United Kingdom; Zimmer, Dover, Ohio; REF 00-2555-050-05.
  • Manufacturer
    Zimmer Inc.
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