Device Recall Optetrak

  • Modèle / numéro de série
    serial numbers: 0900529-0900532
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed to one hospital in New York.
  • Description du dispositif
    Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Société-mère du fabricant (2017)
  • Source
    USFDA

3 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Catalogue number 200-04-45; Serial number range 0730621-07306351; Lot number 452500.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed domestically to Alabama and Louisiana, and internationally to Spain, Germany and Greece.
  • Description du dispositif
    Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONLY FOR CEMENTED USE ONLY***EXACTECH Gainesville, FL 32653***. ''
  • Manufacturer
  • Modèle / numéro de série
    Serial numbers 0886395-0886424
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    International distribution only---- including countries of South America, Africa and Europe
  • Description du dispositif
    Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02
  • Manufacturer
  • Modèle / numéro de série
    Catalog numbers 02-012-35-6011, 02-012-35-6013, 02-012-35-6015 All lots.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    USA ( nationwide) WA, OH, OK, TX, NC, NY, CO, VA, MA, IL, TN, MN, NJ and FL.
  • Description du dispositif
    OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. || There are three product sizes being recalled, 11mm, 13mm, 15mm. All other information is the same. || The Optetrak Logic Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
  • Manufacturer