Devices

Device Recall Foundation

  • Model / Serial
    Catalog number 324-01-106, Lot number 991151
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product was distributed domesically to the following states: IA, MA, OK, TX, FL, CA, and SD. Product was shipped to one distributor in Germany.
  • Product Description
    Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758
  • Manufacturer
    Encore Medical, LP
  • 1 Event

Manufacturer

Encore Medical, LP
  • Manufacturer Address
    Encore Medical, LP, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA

4 devices with a similar name

Learn more about the data here

Device Recall Foundation Porous Coated Hip Stem
  • Model / Serial
    Part number 470-02-090, Lot 938381
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Deerfield Beach, FL
  • Product Description
    HA Hip Stem, cementless
  • Manufacturer
    Encore Medical, Lp
Device Recall Foundation Total Knee System.
  • Model / Serial
    Lot #426142 and #426132.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Device distributed to direct accounts in AZ, CA, FL, GA, MO, NJ, OK, SC, SD and TX. Foreign consignies located in Freiburg and Langelsheim, Germany.
  • Product Description
    Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement.
  • Manufacturer
    Encore Medical, Lp
Device Recall Foundation Baseplate
  • Model / Serial
    Lot number 53986069
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, including states of GA, OK, FL, CA, and SD, and countries of Germany and Turkey.
  • Product Description
    Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, such that plastic inserts of various thicknesses and intramedullary stem are attached to the metal baseplate intraoperatively.
  • Manufacturer
    Encore Medical, Lp
Device Recall Foundation Knee Revision Baseplate
  • Model / Serial
    Lot 53944312
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    TX, FL, GA, CA, AZ, Japan
  • Product Description
    Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left
  • Manufacturer
    Encore Medical, Lp