Home / Recalls / Limacorporate S.p.A / Z-0744-2025

Z-0744-2025 Class II Ongoing

Recalled by Limacorporate S.p.A — San Daniele Del Friuli

Recall Details

Product Type
Devices
Report Date
January 1, 2025
Initiation Date
October 2, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
~87 devices (U.S.)

Product Description

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.

Reason for Recall

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

Distribution Pattern

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

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

Other recalls by Limacorporate S.p.A

  • Z-2024-2025 Class II — PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile (May 19, 2025)
  • Z-2025-2025 Class II — PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile (May 19, 2025)
  • Z-0524-2024 Class II — PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610 (October 27, 2023)
  • Z-0726-2024 Class II — PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Co (August 29, 2023)
  • Z-2010-2023 Class II — REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R (May 30, 2023)
  • Z-2009-2023 Class II — REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R (May 30, 2023)
  • Z-1317-2023 Class II — SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210 (February 21, 2023)
  • Z-1261-2023 Class II — TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of (January 25, 2023)
  • Z-0160-2022 Class II — REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5 (October 1, 2021)
  • Z-0159-2022 Class II — REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5 (October 1, 2021)