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Smith & Nephew, Inc. recalls smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product n
Recalled June 17, 2020 · FDA recall Z-2333-2020 · Smith & Nephew
Hazard
A manufacturing error resulted in out of specification R3 Acetabular Shells · FDA Class II
Units
6468 devices
Sold at
Worldwide
Description
A manufacturing error resulted in out of specification R3 Acetabular Shells
Product
smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558 60MM 71335560 Orthopedic implant component.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →