Device Recall Large Combination Clamp component of Synthes External Fixation System

  • Model / Serial
    Lot Numbers 6602070, 6582333, 6581191, and 6581193
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    USA Nationwide Distribution including the states of AL, AR, AK, CA, FL, ID, KS, LA, MD, MA, MO, NJ, NY, OH, PA, TN, TX, and VA.
  • Product Description
    Large Combination Clamp/Large External Fixation System, Part Number 390.005 || Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
  • 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