Device Recall Finned Tibial Tray

  • Model / Serial
    Serial number range 0696020 - 0696061.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to 15 Domestic Consignees 4 Foreign Distributors.
  • Product Description
    The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SINGLE USE ONLY. FOR CEMENTED USE ONLY***''.
  • Manufacturer
  • 1 Event

Manufacturer

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