Device Recall SecurFit Max Hip Stem

  • Model / Serial
    6051-0625S SECUR-FIT MAX 132 HIP STEM #6 HKNMME, 6051-0730S SECUR-FIT MAX 132 HIP STEM #7 K03MME, 6051-0730S SECUR-FIT MAX 132 HIP STEM #7 K08MME, 6051-0830S SECUR-FIT MAX 132 HIP STEM #8 E56MLE, 6051-0830S SECUR-FIT MAX 132 HIP STEM #8 J41MLE, 6051-0935S SECUR-FIT MAX 132 HIP STEM #9 EN1MME, 6051-1035S SECUR-FIT MAX 132 HIP STEM #10 70PMME, 6051-1140S SECUR-FIT MAX 132 HIP STEM #11 4PMMME, 6051-1140S SECUR-FIT MAX 132 HIP STEM #11 901MME, 6052-0830S SECUR-FIT MAX 127 HIP STEM #8 V3PMLE, 6052-0935S SECUR-FIT MAX 127 HIP STEM #9 5ERMME, 6052-1035S SECUR-FIT MAX 127 HIP STEM #10 69WMME, 6052-1035S SECUR-FIT MAX 127 HIP STEM #10 AL8MME and 6052-1240S SECUR-FIT MAX 127 HIP STEM #12 EP4MME
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
  • Product Description
    Secur-Fit Max Hip Stem || 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
  • 1 Event

Manufacturer

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