Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF ...
FDA Recall #Z-0326-2025 — Class II — October 15, 2024
Product Description
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.
Reason for Recall
The Bipolar assembly contains an oversized Retainer Ring.
Recalling Firm
Smith & Nephew, Inc. — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
21 devices
Distribution
International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.
Code Information
Batch W2401399, UDI-DI 03596010494375.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated