Limacorporate S.p.A: Medical Device Recall in 2023 - (Recall #: Z-1261-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)

Product Classification:

Class II

Date Initiated: January 25, 2023

Date Posted: March 22, 2023

Recall Number: Z-1261-2023

Event ID: 91613

Reason for Recall:

Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.

Status: Ongoing

Product Quantity: 5 systems

Code Information:

Product Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241

Distribution Pattern:

U.S. Distribution to: TX

Voluntary or Mandated:

Voluntary: Firm initiated