Reported Jan 1, 2025 · Ongoing
TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total…
Limacorporate S.p.A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Limacorporate S.p.A · Via Nazionale 52 · San Daniele Del Friuli · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- Product/Catalog Numbers1590.15.010
- TEMA ELBOW - AXLE SMALL UDI-DI code08033390128865
- Lot/Serial Numbers23031752300054 23177372300230 23173852400087
- Product/Catalog Number1590.15.020
- TEMA ELBOW - AXLE LARGE UDI-DI code08033390128872
- Lot/Serial Numbers22276962300054 23325482400047 24006192400193
- Amount recalled
- ~87 devices (U.S.)
Where it was sold
Why it was recalled
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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