Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Tibial Tray Nonporous A Size 4 Recalled by Ortho Development Corporation Due to The locking mechanism of the tibial tray exhibited...
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 Ortho Development Corporation directly.
Affected Products
Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
Quantity: 29
Why Was This Recalled?
The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled.
Where Was This Sold?
This product was distributed to 6 states: CA, FL, OH, PA, TX, UT
About Ortho Development Corporation
Ortho Development Corporation has 8 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report