Devices

Device Recall Stryker Howmedica Osteonics Corp.

  • Model / Serial
    Class I, 510(k) exempt  Catalog Number: 6543-1-600  Lot Number; NE1WR1
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Stryker Orthopaedics || FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS || REF 6543-1-600;NON-STERILE || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 USA || A Subsidiary of Stryker Corp. || Stryker France || ZAC Satolas Green Pusignan || Av de Satolas Green 69881 Meyzieu || Cedex France || The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes. || Made in USA
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
  • 1 Event

Manufacturer

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

2 devices with a similar name

Learn more about the data here

Device Recall Stryker Howmedica Osteonics Corp.
  • Model / Serial
    Class I, 510(k) exempt  Catalog Number: 6543-2-600  Lot Number: P1S43, P2A31
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    Stryker Orthopaedics || TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS || REF 6543-2-600;NON-STERILE || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 USA || A Subsidiary of Stryker Corp. || Stryker France || ZAC Satolas Green Pusignan || Av de Satolas Green 69881 Meyzieu || Cedex France || Made in USA || The Offset Bushings are parts of the Triathlon TS system. They are used during trialing to assess the appropriate magnitude and orientation of offset between the Implant and the intramedullary Stem. The feedback from the Offset Bushing allows for the selection of the corresponding Offset Adaptor, which allows for optimal bone coverage, compensating for differences between the Implant and bone canal axes.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.
Device Recall Stryker Howmedica Osteonics Corp.
  • Model / Serial
    Catalog Number: 6266-0-100 Lot Code: RD6W017, RD7L234X, RD7L234, RD7L235, RD5T305A, RD6W017J, RD6W017A, RD5T307, RD5T305T, RD5T305M, RD5T305L, RD5T306X, RD5T305, RD5T306
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
  • Manufacturer
    Stryker Howmedica Osteonics Corp.