Z-1622-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2024
- Initiation Date
- February 27, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45 units
Product Description
TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-48D
Reason for Recall
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Distribution Pattern
Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Code Information
UDI-DI: (01)07613327380903(17)290313(10) Lot Number: 14875651 15005253 16044255