FDA Device recall Z-0326-2025
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 co…
- FDA Device
- Class II
- ongoing
- Published 2024-11-13
On 2024-11-13 the FDA classified a Class II recall of 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 co… by Smith And Nephew, citing the Bipolar assembly contains an oversized Retainer Ring.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0326-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-15 |
| Published | 2024-11-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Smith And Nephew |
| Distribution | n/a |
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.
Reason
The Bipolar assembly contains an oversized Retainer Ring.
Identifiers
| code_info | Batch W2401399, UDI-DI 03596010494375. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0326-2025%22
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