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Smith & Nephew, Inc. recalls smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product numb
Recalled June 17, 2020 · FDA recall Z-2331-2020 · Smith & Nephew
Hazard
A manufacturing error resulted in out of specification R3 Acetabular Shells · FDA Class II
Units
1267 devices
Sold at
Worldwide
Description
A manufacturing error resulted in out of specification R3 Acetabular Shells
Product
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.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →