Device Recall Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm

  • Model / Serial
    Part Numbers: 03.037.013, 03.037.014, Lot Numbers: 8903848, 9124017, 903851, 9124019, 8918566, 9124022, 9124012, 9124023, 9124014, 9124026,  9124016, 9124027, 8918563
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution - NY, TX, MD, OR, MS, ND, CA, AZ, MI, IL, PA, TN, AR, SD, SC, FL, VA, OK, and GA
  • Product Description
    Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aiming Arm and 125 Degree Aiming Arm are a part of the TFN-ADVANCED (TFNA) System. The TFN-ADVANCED Proximal Femoral Nailing System is intended for treatment of fractures in adults and adolescents (12-21) in which the growth plates have fused.
  • Manufacturer
  • 1 Event

Manufacturer

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