Device product
TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-52E
Z-1624-2024
Product summary
- Event
- Event 94215
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 48 units
- Official record key
device-enforcement:Z-1624-2024
Official wording
Reason: The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Code information: UDI-DI: (01)07613327380859(17)290313(10 Lot Number: 14875853 14875852
Distribution pattern: Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Derived failure modes
-
Unknown
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell