Z-2070-2012 Class II Terminated
FDA device recall Z-2070-2012 was initiated by Exactech, Inc. on Sep 23, 2011 and is designated Class II. Reason for recall: Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1F/1T, 2F/1T and the Optetrak Rotating Bearing Knee Tibial Tray, Finned, Cemented Tibial Tray, Size… The recall status is terminated (terminated Jun 11, 2014). Affected quantity: 16.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 1, 2012
- Initiation Date
- Sep 23, 2011
- Termination Date
- Jun 11, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16
Product Description
Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***". The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the Optetrak Comprehensive Knee System is indicated for cemented use only.
Reason for Recall
Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1F/1T, 2F/1T and the Optetrak Rotating Bearing Knee Tibial Tray, Finned, Cemented Tibial Tray, Size 2F/1T. Both trays have the potential to be mislabeled.
Distribution Pattern
Worldwide Distribution-USA-including the states of CA, MA, OH, and OK, and the countries of Brazil, Colombia, France, Italy, Japan, Luxembourg, and Spain.
Code Information
Serial number range 2067442 - 2067457.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2070-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026