Device Recall HA Generation II

  • Model / Serial
    540-11-52E TRIDENT PSL HA SOLID BACK 52mm 8NKMJD 540-11-54F TRIDENT PSL HA SOLID BACK 54mm 3H7MJD 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 78AMJD 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 9T9MJD 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 4THMJD 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 4TJMJD 540-11-66I TRIDENT PSL HA SOLID BACK 66mm RLKMHD 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 1WNMJD
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product was distributed nationwide and one unit to Brazil.
  • Product Description
    HA Solid Back Acetabular Shell; || Arc Deposited HA Coated Included Dome hole Plug; Hip prosthesis component. || Sterile; made in USA; || Howmedica Osteonics Corp.; || 325 Corporate Drive; || Mahwah, NJ 07430 || A Subsidiary of Stryker Corp.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
  • Source
    USFDA