FDA-Device2024-06-05Class II

smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4

Smith & Nephew Inc
Hazard

Packaging contained the incorrect size of femoral head from what was displayed on the label.

Sold states
International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.
Affected count
23 packages
Manufactured in
6409 E Holmes Rd, Memphis, TN, United States
Products
smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1901-2024

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