Events

Recall of Device Recall OPTETRAK Knee Prosthesis

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Exactech, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    34294
  • Event Risk Class
    Class 2
  • Event Number
    Z-0927-06
  • Event Initiated Date
    2005-12-19
  • Event Date Posted
    2006-06-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43488
  • Notes / Alerts
    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.
  • Extra notes in the data
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
  • Reason
    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.
  • Action
    Each consignee contacted by mail 12/19/2005, and asked to return the product to Exactech. The returned product will be quarantined and evaluated.

Device

Device Recall OPTETRAK Knee Prosthesis
  • Model / Serial
    Catalogue number 200-04-45; Serial number range 0730621-07306351; Lot number 452500.
  • Product Classification
    Orthopedic Devices
  • 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
    Exactech, Inc.

Manufacturer

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