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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, femo
Recalled November 13, 2024 · FDA recall Z-0326-2025 · Smith & Nephew
Hazard
The Bipolar assembly contains an oversized Retainer Ring. · FDA Class II
Units
21 devices
Sold at
International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.
Description
The Bipolar assembly contains an oversized Retainer Ring.
Product
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.
Manufacturer(s)
Smith & Nephew, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →