FDA Enforcement
Class II
Ongoing
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F
Recall: Z-1626-2024
·
Reported May 1, 2024
Enforcement
- Recall Number
- Z-1626-2024
- Event ID
- 94215
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Howmedica Osteonics Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 1, 2024
- Initiation Date
- February 27, 2024
- Classification Date
- April 25, 2024
- Address
- 325 Corporate Dr, N/A, Mahwah, NJ, 07430-2006, United States
Description
TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-58F
Reason
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Code Info
UDI-DI: (01)07613327380958(17)290313(10) Lot Number: 15854353
Distribution
Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
Quantity
0