Z-2071-2012 Class II Terminated
FDA device recall Z-2071-2012 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: 12.
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
- 12
Product Description
Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesville, FL 32653-1630***. The Exactech Optetrak RBK Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for knee pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders and/or avascular necrosis of the femoral condyle, post-traumatic loss of the joint configuration (particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Additionally, the Optetrak RBK Total Knee System is indicated for cases where revision of failed previous surgical attempts is necessary, if the knee can be satisfactorily balanced and stabilized at the time of surgery.
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 2067544 - 2067555.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2071-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026