Medical device recalls Moderate risk

Smith & Nephew, Inc. recalls smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product…

Recall date
April 22, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2335-2020
FDA classification
Class II
Brand / firm
Smith & Nephew, Inc.
Sold / distributed
Worldwide

Why it was recalled

A manufacturing error resulted in out of specification R3 Acetabular Shells

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

What was recalled

smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.

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