Medical device recalls Moderate risk

Smith & Nephew, Inc. recalls smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product numb…

Recall date
April 22, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2331-2020
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 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.

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