Medical device recalls Moderate risk

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

Recall date
April 22, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2336-2020
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 HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant component.

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