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Recall Observatory FDA recall evidence

Device product

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.

Z-0744-2025

October 02, 2024

Class II

Product summary

Firm
Limacorporate S.p.A
Event
Event 95732
Status
Ongoing
Classification
Class II
Quantity
~87 devices (U.S.)
Official record key
device-enforcement:Z-0744-2025

Official wording

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

Code information: 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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