Device Recall TI NHance Rod 150mm Sterile

  • Model / Serial
    Catalog number 04.600.715.02S. Lot numbers: 5764185 and 5764346
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OR, PA, SC, TN , TX, UT, VA, WA, WI, and WV and countries including Denmark, Germany, Korea and Switzerland.
  • Product Description
    TI N-Hance Rod 150mm Sterile || The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.
  • Manufacturer
  • 1 Event

Manufacturer

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