Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 1, 2012
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 jo
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 T…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Exactech, Inc. recalled Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Al… - a moderate-severity action.
Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Al… was recalled by Exactech, Inc. in August 1, 2012. Reason: Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1F/1T, 2F/1T …. Check the official notice for the remedy. Verify recall #Z-2071-2012 with the FDA Devices before acting.
The recall
Exactech, Inc. issued this moderate-severity FDA Devices recall-Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1F/1T, 2F/1T ….
- Moderate
- severity level
- 12 units
- affected scope
- Class II
- classification
- August 1, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2071-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2071-2012) was formally reported on August 1, 2012, with the manufacturer initiating the action on September 23, 2011. It is classified under Moderate severity (Class II), with a current status of Terminated. Exactech, Inc. is listed as the recalling firm, operating out of Gainesville, FL. Federal records list the affected scope as 12.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide Distribution-USA-including the states of CA, MA, OH, and OK, and the countries of Brazil, Colombia, France, Italy, Japan, Luxembourg, and Spain.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
12
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2071-2012 |
| Date reported | August 1, 2012 |
| Date initiated | September 23, 2011 |
| Recalling firm | Exactech, Inc. |
| Firm location | Gainesville, FL |
| Affected scope | 12 |
| Distribution | Worldwide Distribution-USA-including the states of CA, MA, OH, and OK, and the countries of Brazil, Colombia, France, Italy, Japan, Luxembourg, and Spain. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2071-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Exactech, Inc.. Units affected: 12.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 1, 2012. Severity: Moderate. Recall number: Z-2071-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-USA-including the states of CA, MA, OH, and OK, and the countries of Brazil, Colombia, France, Italy, Japan, Luxembourg, and Spain..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2071-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 1, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.