Z-0326-2025 Class II Ongoing
FDA device recall Z-0326-2025 was initiated by Smith & Nephew, Inc. on October 15, 2024 and is designated Class II. Reason for recall: The Bipolar assembly contains an oversized Retainer Ring. The recall status is ongoing. Affected quantity: 21 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2024
- Initiation Date
- October 15, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 devices
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.
Distribution Pattern
International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.
Code Information
Batch W2401399, UDI-DI 03596010494375.