Reported Mar 22, 2023 · Ongoing
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Limacorporate S.p.A
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Limacorporate S.p.A · Via Nazionale 52 · San Daniele Del Friuli, N/A · N/A
Is this the product you have?
- TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
- Lot codes and dates
- Product Code1590.15.010
- UDI-DI Code08033390128865
- Lot Number2115522
- Sterilization Lot Number2100241
- Amount recalled
- 5 systems
Where it was sold
Why it was recalled
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
This product could cause temporary or reversible health problems — stop using it.
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