Devices

Device Recall Accolade HFx

  • Model / Serial
    6077-0230 Accolade HFx Size #2 8XAMLE, 6077-0230 Accolade HFx Size #2 8XEMLE, 6077-0335 Accolade HFx Size #3 8PAMME, 6077-0435 Accolade HFx Size #4 8PEMME, 6077-0435 Accolade HFx Size #4 PJLMLE and 6077-0435 Accolade HFx Size #4 R27MLE
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
  • Product Description
    Accolade HFx || These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event

Manufacturer

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