Devices

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.
1 Event
- Recall of Device Recall OPTETRAK Knee Prosthesis

Manufacturer

Exactech, Inc.

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

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)