Howmedica Osteonics Corp. Recall 94215
Description: TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H
Howmedica Osteonics Corp. Recall 94215 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-1627-2024 |
Event ID | 94215 |
Event Description | TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-66H |
Product Type | Devices |
Distribution | Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK |
Recall Reason | The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell |
Device Classification | 20240501 |
Device Code Info | UDI-DI: (01)07613327380835(17)290313(10) Lot Number: 15445252 |
Center Classification Date | 20240425 |
Recall Initiation Date | 20240227 |
Recalling Firm | Howmedica Osteonics Corp. |
Initial Notification | Letter |
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