Smith & Nephew, Inc.: Device Recall

Recall #Z-0326-2025 · 10/15/2024

Class II: Risk

Recall Details

Recall Number: Z-0326-2025
Classification: Class II
Product Type: Device
Recalling Firm: Smith & Nephew, Inc.
Status: Ongoing
Date Initiated: 10/15/2024
Location: Memphis, TN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 21 devices

Reason for Recall

The Bipolar assembly contains an oversized Retainer Ring.

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.

Distribution Pattern

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

Other Recalls by Smith & Nephew, Inc.

Class II: Risk 11/24/2025

Removal of affected lot of screws due to labeling error.
Class II: Risk 03/18/2025

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
Class II: Risk 10/29/2024

Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Class II: Risk 10/02/2024

Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
Class II: Risk 10/02/2024

Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.

View all recalls by Smith & Nephew, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.