Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Recalled by Limacorporate S.p.A Due to Due to a potential difference in mechanical behavior...
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 Limacorporate S.p.A directly.
Affected Products
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.
Quantity: ~87 devices (U.S.)
Why Was This Recalled?
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
Where Was This Sold?
This product was distributed to 2 states: FL, TX
About Limacorporate S.p.A
Limacorporate S.p.A has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report