Device Recall Stryker Trio 3.5.MM Hex Socket

  • Model / Serial
    Catalog number 48906075, all lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide - OR, AR, CA, MA, KY, MD, GA, FL, NY, NM, UT, FL, OK, KS, MI, MN, IN, MT, TX, WI, and TN.
  • Product Description
    Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM || Not Sterile: || Manufactured by: Stryker Spine SAS, Cestas, France; || Distributed in the USA by: Stryker Spine, Allendale, NJ 07401 || The Trio 3.5MM Hex Socket is a reusable instrument, sterilized prior to use, used with the Trio Torque Wrench to facilitate final tightening of Trio connectors and 3.5MM Hex Screw Assembly. This Trio 3.5MM Hex Socket is used with the Trio implant system for posterior noncervical pedical and non pedical fixation of the spine.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Manufacturer Parent Company (2017)
  • Source
    USFDA