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Recall Observatory FDA recall evidence

Device product

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

Z-1261-2023

January 25, 2023

Class II

Product summary

Firm
Limacorporate S.p.A
Event
Event 91613
Status
Ongoing
Classification
Class II
Quantity
5 systems
Official record key
device-enforcement:Z-1261-2023

Official wording

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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