CLASS II ONGOING Device recall · Reported 1 Jan 2025 · FDA Enforcement Report

TEMA Elbow - Axle Small recalled by Limacorporate S.p.A

Limacorporate is recalling TEMA Elbow - Axle Small, distributed in Florida, Texas. The recall was initiated on 2 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct/Catalog Numbers: 1590.15.010 TEMA ELBOW - AXLE SMALL UDI-DI code: 08033390128865 Lot/Serial Numbers: 23031752300054 23177372300230 23173852400087 Product/Catalog Number: 1590.15.020 TEMA ELBOW - AXLE LARGE UDI-DI code: 08033390128872 Lot/Serial Numbers: 22276962300054 23325482400047 24006192400193

Quantity recalled~87 devices (U.S.)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0744-2025
FDA event ID: 95732
Recalling firm: Limacorporate, San Daniele Del Friuli
Classification: Class II
Status: Ongoing
Recall initiated: 2 Oct 2024
FDA classified: 20 Dec 2024
Reported: 1 Jan 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Oct 2024	Recall initiated by company
20 Dec 2024	Classified by FDA	+79 days
1 Jan 2025	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.

Product as listed by the FDA

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.

Where it was distributed

U.S: FL and TX O.U.S.: N/A

Florida Texas

Questions about this recall

Why was it recalled?

Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.

Which lots are affected?

Product/Catalog Numbers: 1590.15.010 TEMA ELBOW - AXLE SMALL UDI-DI code: 08033390128865 Lot/Serial Numbers: 23031752300054 23177372300230 23173852400087 Product/Catalog Number: 1590.15.020 TEMA ELBOW - AXLE LARGE UDI-DI code: 08033390128872 Lot/Serial Numbers: 22276962300054 23325482400047 24006192400193

Where was it sold?

U.S: FL and TX O.U.S.: N/A

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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