FDA-Device2020-06-17Class II
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.
Smith & Nephew, Inc.
Hazard
A manufacturing error resulted in out of specification R3 Acetabular Shells
Sold states
Worldwide
Affected count
1267 devices
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2331-2020Don't want to check this manually?
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