U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
An implant within a lot of finned tibial trays manufactured at exactech was not made to specification. the locking cavity in the tibial tray was not fully machined thus preventing the tibial insert from locking in place.
조치
Each consignee contacted by mail 12/19/2005, and asked to return the product to Exactech. The returned product will be quarantined and evaluated.
Distributed domestically to Alabama and Louisiana, and internationally to Spain, Germany and Greece.
제품 설명
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***. ''