FDAFDA · Food and drugs·Recall number Z-2318-2024
9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Published July 17, 2024 · Recall initiated: April 10, 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
Due to incorrect milled titanium abutment being packaged and labeled.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Preat Corp
- Distributor
- U.S.: CA, MO, and NV. O.U.S.: None
- Lot
- Model Number: 9006767 UDI-DI code: 00842092159477 Lot Numbers: ED11-20247825, ED11-20248895, ED11-20249165 and 241588
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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