Device product
TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-50D
Z-1629-2024
Product summary
- Event
- Event 94215
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 0
- Official record key
device-enforcement:Z-1629-2024
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)07613327381009(17)290313(10) Lot Number: 14593551 15432653 15432651
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