FDA-Device2020-06-17Class II
smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.
Smith & Nephew, Inc.
Hazard
A manufacturing error resulted in out of specification R3 Acetabular Shells
Sold states
Worldwide
Affected count
1766 devices
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2335-2020Don't want to check this manually?
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