FDA-Device2020-06-17Class II
smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant component.
Smith & Nephew, Inc.
Hazard
A manufacturing error resulted in out of specification R3 Acetabular Shells
Sold states
Worldwide
Affected count
58 devices
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant component.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2336-2020Don't want to check this manually?
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