Smith & Nephew, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0326-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 15, 2024

Date Posted: November 13, 2024

Recall Number: Z-0326-2025

Event ID: 95568

Reason for Recall:

The Bipolar assembly contains an oversized Retainer Ring.

Status: Ongoing

Product Quantity: 21 devices

Code Information:

Batch W2401399, UDI-DI 03596010494375.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated