Device Recall NFlex Straight monosegmental L 150mm

  • Model / Serial
    Catalog number 04.600.716.02S. Lot numbers: 5794446 and 5842468
  • 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
    NFlex Straight monosegmental L 150mm || 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