Device Recall GEM 2753 Microvascular Anastomotic Coupler

  • Model / Serial
    Lot numbers: 1808, 1894, 1907, 1923, 1953, 1954, 7139, 7211, 7354, 8998, 8999, 11591, 12364, 15244, 15280, 15281, 18824, 18912, 19294, 19413, 19954, 20263, 20689, 21345, 21515, 21560, 21977, 22556, and 23047
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Canada, Japan, UAE, Korea, South Africa, Australia, Taiwan, Norway, Netherlands, Sweden, Greece, Norway, Turkey, Portugal, Taiwan, Denmark, Italy, Germany, Japan, Spain, Austria, and Great Britain.
  • Product Description
    GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010, Rx only, Irradiation Sterilized || This is a microsurgical coupler used in the anastomosis of veins and arteries normally encountered in microsurgical vascular reconstructive procedures.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Synovis Micro Companies Alliance Inc, 439 Industrial Ln, Birmingham AL 35211-4464
  • Manufacturer Parent Company (2017)
  • Source
    USFDA