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Smith & Nephew, Inc. recalls smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF
Recalled June 17, 2020 · FDA recall Z-2336-2020 · Smith & Nephew
Hazard
A manufacturing error resulted in out of specification R3 Acetabular Shells · FDA Class II
Units
58 devices
Sold at
Worldwide
Description
A manufacturing error resulted in out of specification R3 Acetabular Shells
Product
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.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →