Exactech Recalls Optetrak Tibial Trays Due to Potential Mislabeled Components
Exactech is recalling 12 Optetrak tibial trays because they have the potential to be mislabeled. The affected trays were distributed in the US and several international countries.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the hazard as a potential labeling error without reporting any injuries, illnesses, or specific structural defects. This aligns with the rubric for moderate severity involving minor labeling errors or precautionary measures.
Plain-English summary
Exactech, Inc. is recalling 12 units of the Optetrak Cemented Trapezoid Tibial Tray (Sizes 1F/1T and 2F/1T) and the Optetrak Rotating Bearing Knee Tibial Tray (Finned, Cemented, Size 2F/1T). The recall is being conducted because these specific trays have the potential to be mislabeled.
The affected devices are identified by serial numbers ranging from 2067544 to 2067555. The product is labeled with the reference number 260-04-21 and is manufactured by Exactech, Inc. in Gainesville, FL. The Optetrak RBK Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for knee pain and disability due to various conditions, including rheumatoid arthritis and osteoarthritis.
The recalled trays were distributed worldwide, including in the United States (specifically California, Massachusetts, Ohio, and Oklahoma) and in Brazil, Colombia, France, Italy, Japan, Luxembourg, and Spain. No specific instructions for consumers are provided in the source text, but the recall is limited to the 12 units with the specified serial numbers.
The recalled product
- Product
- 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…
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial number range 2067544 - 2067555.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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