FDA recall Z-1901-2024

Product

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

Reason for recall

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

Distribution

International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.

Key facts

Status

Ongoing

Initiation date

2024-04-24

Report date

2024-06-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

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