Limacorporate S.p.A recalls TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total e…
- Recall date
- October 2, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0744-2025
- FDA classification
- Class II
- Brand / firm
- Limacorporate S.p.A
- Sold / distributed
- U.S: FL and TX O.U.S.: N/A
Why it was recalled
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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