• Model / Serial
    lot no.: 61996176 61996176N 61996177 61996177N 61687334 61926537 62308501 61811187 61996179 61996179N
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Product 52 consists of product code: HWC and same usage: || Item no: || 525004530 NEXGEN OSTEOTOMY CORT BON || 525004540 NEXGEN OSTEOTOMY CORT BON || 525006545 NEXGEN OSTEOTOMY CORT BON || 525006560 NEXGEN OSTEOTOMY CORT BON || 525006565 NEXGEN OSTEOTOMY CORT BON || for use in total knee arthroplasty
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • Manufacturer Parent Company (2017)
  • 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

  • Model / Serial
    Lots 00111581, 61229463, 61232451, 61284938 and 61284939.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States, France, Germany, Italy, Switzerland and United Kingdom.
  • Product Description
    Zimmer Natural Nail System, Antegrade Femoral Interlock Module, standard, nonsterile, Zimmer, Warsaw, IN; REF 00-2490-001-03. || The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone.
  • Manufacturer
  • Model / Serial
    Workstation serial numbers SP014, SP015, SP019 through SP022, SP025 through SP033, SP035, SP038, SP039, SP043, SP044, SP047, SP049, SP052, SP057, SP058, SP060, SP061, SP062, SP064, SP065, SP069, SP072, SP074 through SP083, SP089, SP090, SP091, SP093, SP094, SP098, SP099, SP121, SP124, SP125, SP127, SP128, SP131 through SP135, SP151 through SP154, SP157, SP175, SP176, SP183, SP184, SP185, SP190 and SP198.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Zimmer/CAS Power Cord, Sesamoid Plasty, NA, Zimmer/CAS, Montreal (Quebec), Canada; REF 20-8000-070-12. The device is the power cord component for the Sesamoid Plasty CAS workstation which connects the workstation to the power mains.
  • Manufacturer
  • Model / Serial
    Lots 61233652, 61238956, 61245049, 61252577, 61256798, 61263053, 61314067 and 61341224.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Ohio, Canada and France.
  • Product Description
    Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile, Zimmer Dental, Inc., Carlsbad, CA; REF AVACT.
  • Manufacturer
  • Model / Serial
    Lot 61042477.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide, Korea and Switzerland.
  • Product Description
    Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C, right, for cemented use only; REF 00-5764-013-52.
  • Manufacturer
  • Model / Serial
    All lots. Lots 00111134, 60747593, 60747594, 60752676, 60752677, 60760248, 60768076, 60821507, 60824004, 60830411, 60830412, 60845351, 60850604, 60852670, 60852671, 60860895, 60866613, 60872311, 60879050, 60892605, 60900745, 60907449, 60917234, 60922494, 60938889, 60938890, 60947027, 60947028, 60963035, 60963036, 60963037, 60963039, 60983254, 61015851, 61028168, 61033723, 61033724, 61068387, 61068388, 61068389, 61074754, 61074755, 61084771, 61096604, 61116246, 61116247, 61137056, 61143427, 61149041, 61157940, 61173295, 61193516, 61193520, 61198179, 61204038, 61215644, 61225562, 61235612, 61240323, 61248321, 61259184, 61263170, 61272449, 61285508, 61298201, 61306497, 61280371, 61315873, 61319581 and 61329266.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Saudi Arabia, Spain, Sweden, Switzerland and the United Kingdom.
  • Product Description
    Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology Tibial Tray, fixed bearing, size 8, sterile, Zimmer, Warsaw, Indiana; REF 00-5954-057-02. || The product is used as an implant for knee replacement.
  • Manufacturer
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