Device Recall 3DKNEE

  • Modelo / Serial
    Catalog number 333-02-106; Lot numbers 991141 and 991131
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Product was distributed domesically to the following states: IA, MA, OK, TX, FL, CA, and SD. Product was shipped to one distributor in Germany.
  • Descripción del producto
    3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Encore Medical, LP, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA

5 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Lot # 292G1910
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY.
  • Descripción del producto
    3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, || The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
  • Manufacturer
  • Modelo / Serial
    Lot # 339G1045
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY.
  • Descripción del producto
    3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 || The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.
  • Manufacturer
  • Modelo / Serial
    Lot #434322.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    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.
  • Descripción del producto
    Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement.
  • Manufacturer
  • Modelo / Serial
    Lot #53906407
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distribution --- country of Germany.
  • Descripción del producto
    3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. || Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability.
  • Manufacturer
  • Modelo / Serial
    Size 8, Left, Part # 333-01-108, Lot# A1000003
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Florida, Missouri, and Italy
  • Descripción del producto
    3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003.
  • Manufacturer