Class II

Medical Device Recall: Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.

Smith & Nephew, Inc. · October 15, 2024

Reason for Recall

The Bipolar assembly contains an oversized Retainer Ring.

Distribution

International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.

Quantity Affected

21 devices

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0326-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.