Device Recall Stryker Orthopaedics

  • Modèle / numéro de série
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. || The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Société-mère du fabricant (2017)
  • Source
    USFDA

59 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Catalog #5901-S-4818, Lot MAC7C14.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide
  • Description du dispositif
    ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog number 5901-S-4818. Orthopedic manual surgical instrument. || Howmedica Osteonics Corp. || A Subsidiary of Stryker Corp. || Stryker France || Non-sterile || Made in Cork Ireland
  • Manufacturer
  • Modèle / numéro de série
    Catalog Number 5532-G-511 Lot LD8D7Y  Catalog Number 5537-G-319 Lot TT6JT2
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide
  • Description du dispositif
    Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm || Product Usage: || The Triathlon PS X3 (posterior stabilized), cat no 5532-G-xxx and X3 TS (total stabilizing) Plus, cat. no. 5537-G-XXX, Tibial Inserts are used in TKA surgeries. During surgery, the tibial insert is locked into the tibial baseplate where it serves as the bearing component for the articulating surface of a corresponding Triathlon femoral component.
  • Manufacturer
  • Modèle / numéro de série
    Catalog number 5530-G-209   Lot Code LEF064
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    OH, SC, RI, WV
  • Description du dispositif
    Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR || REF 5530-G-209 (component of the Triathlon Total Knee System) for fixation to the tibial baseplates via a locking wire mechanism.
  • Manufacturer
  • Modèle / numéro de série
    Lot Code 3Y0KHP
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in WI.
  • Description du dispositif
    Trident 10 degrees X3 Insert 36 mm ID || Catalog #623-10-36I || Hip implant component
  • Manufacturer
  • Modèle / numéro de série
    Catalog No: I-K3254TA00 Lot Nos: F6E13243, F6L13864, F6M14078, F6S14667, F6S14831, F6W15444, F6W15406, F7C15943, F7H16099 and F7L16994
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution to FL, IN, LA, NC, PA, TN and UT
  • Description du dispositif
    Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock, Non-Sterile, || Used to complement or replace the standard instruments used during the implantation of hip, knee, trauma and upper extremities implants
  • Manufacturer
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