Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Optetrak Offset Tibial Tray and Screws Recalled by Exactech, Inc. Due to There is a design incompatibility between certain sizes...
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 Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX.
Quantity: 720 devices
Why Was This Recalled?
There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
Where Was This Sold?
This product was distributed to 10 states: AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA
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