Device 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.
Z-0326-2025
Product summary
- Event
- Event 95568
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 21 devices
- Official record key
device-enforcement:Z-0326-2025
Official wording
Reason: The Bipolar assembly contains an oversized Retainer Ring.
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.
Derived failure modes
-
Unknown
The Bipolar assembly contains an oversized Retainer Ring.