FDA-Device2020-06-17Class II
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.
Smith & Nephew, Inc.
Hazard
A manufacturing error resulted in out of specification R3 Acetabular Shells
Sold states
Worldwide
Affected count
1450 devices
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2332-2020Don't want to check this manually?
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