FDAFDA · Food and drugs·Recall number Z-1625-2024
TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E
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)07613327380880(17)290313(10) Lot Number: 15293151 15293153 15293152 15432252 15432254 15432451 15432351 15432251 15432253 16265752
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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