Zimmer Gender Solutions

  • Model / Serial
    Item Number 00-5927-040-00 Serial Number All
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide. CANADA HONG KONG KOREA SINGAPORE CHINA VENEZUELA AUSTRALIA JAPAN NETHERLANDS GERMANY INDIA TAIWAN
  • Product Description
    Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis || Milling Handpiece
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Zimmer Biomet, Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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

62 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Number: 60998487.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US including states of FL, MN, MS, NY, OH, TN, TX and WI and Switzerland.
  • Product Description
    Zimmer Gender Solutions Natural Knee Flex System, Gender Solutions Male, Femoral Component, nonporous, size 4, left, sterile, Zimmer, Warsaw, IN; Product Number: 00-5410-017-01. || Knee implant used to replace the distal surface of the human femur in total knee arthroplasty surgery. For use in Non-inflammatory Degenerative Joint Disease or Inflammatory Joint Disease, deformity, moderate contracture or failed previous surgery. Product is indicated for uncemented or cemented use.
  • 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
    Lots 60930892, 60947723, 60954146, 60954147, 60958265, 60958284, 60988214, 61001538, 61005431, 61012248, 61023607, 61027911, 61036361, 61045090, 61058607, 61064796, 61069402, 61075249, 61085866, 61091187, 61096344, 61101443, 61114171 and 61136939.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain and Switzerland.
  • Product Description
    Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 9 MM height, use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-010-09 || The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
  • Manufacturer
  • Model / Serial
    Lots 60930893, 60947729, 60954138, 60954148, 60958267, 60964475, 60971780, 60987831, 60992913, 61001539, 61005445, 61023608, 61036333, 61036334, 61036362, 61058581, 61058608, 61069403, 61075250, 61085867, 61091188, 61096345, 61101444 and 61114172.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain and Switzerland.
  • Product Description
    Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 11 MM height, use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-010-11. || The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
  • Manufacturer
  • Model / Serial
    Lots 60943097, 60943098, 60958268, 60964476, 60971781, 60988215, 60992914, 60992915, 61001540, 61005432, 61012249, 61036335, 61036336, 61036363, 61058609, 61064797,  61069404, 61075251, 61085868, 61091189, 61101445 and 61114161.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain and Switzerland.
  • Product Description
    Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 13 MM height, use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-010-13. || The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
  • Manufacturer
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