FDA-Device2024-11-13Class II
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.
Hazard
The Bipolar assembly contains an oversized Retainer Ring.
Sold states
International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.
Affected count
21 devices
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0326-2025Don't want to check this manually?
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