Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. Recalled by Exactech, Inc. Due to Inserts were packaged in vacuum bags that lacked...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Exactech, Inc. directly.
Affected Products
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
Quantity: 33,103 devices
Why Was This Recalled?
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Exactech, Inc.
Exactech, Inc. has 211 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report