FDAFDA · Food and drugs·Recall number Z-1623-2024
TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-50D
Published May 1, 2024 · Recall initiated: February 27, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Howmedica Osteonics Corp.
- Distributor
- Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UK
- Lot
- UDI-DI: (01)07613327381047(17)290313(10) Lot Number: 14629051 14628851 15175654 15610452
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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