Medical device recalls Moderate risk

Limacorporate S.p.A recalls PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile

Recall date
May 19, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2025-2025
FDA classification
Class II
Brand / firm
Limacorporate S.p.A
Sold / distributed
Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, TX and the countries of Italy, Poland, France.

Why it was recalled

There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile

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