Smith & Nephew, Inc. recalls Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, fem…
- Recall date
- October 15, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0326-2025
- FDA classification
- Class II
- Brand / firm
- Smith & Nephew, Inc.
- Sold / distributed
- International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.
Why it was recalled
The Bipolar assembly contains an oversized Retainer Ring.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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