Device Recall Synthes 3.2 mm Guide Wire 400mm

  • Model / Serial
    part No. 357.399 with all lot numbers 4440270 through 49991803, 5000218 through 5894644, 6000409 through 6999404, 7000143 through 7531836, UK09636, UK10233, UK10510, UL11099, and UL11333.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland.
  • Product Description
    Synthes 3.2 mm Guide Wire 400mm. || Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
  • Source
    USFDA