Device Recall OPTETRAK Knee Prosthesis

  • Model / Serial
    Catalogue number 200-04-45; Serial number range 0730621-07306351; Lot number 452500.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed domestically to Alabama and Louisiana, and internationally to Spain, Germany and Greece.
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Manufacturer Parent Company (2017)
  • Source
    USFDA