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Smith & Nephew, Inc. recalls smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF
Recalled June 17, 2020 · FDA recall Z-2334-2020 · Smith & Nephew
Hazard
A manufacturing error resulted in out of specification R3 Acetabular Shells · FDA Class II
Units
4172 devices
Sold at
Worldwide
Description
A manufacturing error resulted in out of specification R3 Acetabular Shells
Product
smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM 71331962 64MM 71331964 68MM 71331968 Orthopedic implant component.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →