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Smith & Nephew, Inc. recalls smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/
Recalled June 17, 2020 · FDA recall Z-2332-2020 · Smith & Nephew
Hazard
A manufacturing error resulted in out of specification R3 Acetabular Shells · FDA Class II
Units
1450 devices
Sold at
Worldwide
Description
A manufacturing error resulted in out of specification R3 Acetabular Shells
Product
smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 71332254 56MM 71332256 58MM 71332258 60MM 71332260 62MM 71332262 64MM 71332264 Orthopedic implant component.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →