smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&neph...
FDA Recall #Z-1901-2024 — Class II — April 24, 2024
Product Description
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.
Recalling Firm
Smith & Nephew Inc — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
23 packages
Distribution
International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.
Code Information
REF 71343204 - Batch #23FM03219, Exp. June 2033; REF 71343604 - Batch 23FM04184, Exp. June 2033.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated