Device Recall Stryker Orthopaedics

Fabricant

  • Adresse du fabricant
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • 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
    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
  • Modèle / numéro de série
    Catalog #5901-1038
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Reunion TSA Peg Alignment Sound || Catalog #5901-1038 || The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant prior to final implantation into the glenoid vault. Its purpose is to provide assurance that the drilled holes for seating of the Glenoid implant have been properly prepared using the provided instrumentation
  • Manufacturer
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