Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC Recalled by Arthrex, Inc. Due to Devices reported to have a smooth texture to...
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 Arthrex, Inc. directly.
Affected Products
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).
Quantity: 2,378 units.
Why Was This Recalled?
Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Arthrex, Inc.
Arthrex, Inc. has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report