Limacorporate S.p.A: 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.

Hazard

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

Details from the source

Reason for recall: Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery. Distribution: U.S: FL and TX O.U.S.: N/A Quantity: ~87 devices (U.S.) Lot/code info: 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

UPC codes

08033390128865, 23031752300054, 23177372300230, 23173852400087, 08033390128872, 22276962300054, 23325482400047, 24006192400193

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.