PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: June 5, 2024 Initiated: April 24, 2024 #Z-1901-2024

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.

Details

Recalling Firm
Smith & Nephew Inc
Units Affected
23 packages
Distribution
International distribution to the countries of Australia, Germany, Japan, Portugal, and United Kingdom.
Location
Memphis, TN

Frequently Asked Questions

What product was recalled?
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. Recalled by Smith & Nephew Inc. Units affected: 23 packages.
Why was this product recalled?
Packaging contained the incorrect size of femoral head from what was displayed on the label.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 5, 2024. Severity: Moderate. Recall number: Z-1901-2024.