FDAFDA · Food and drugs·Recall number Z-0074-2021
BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
Published October 14, 2020 · Recall initiated: August 31, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared with the provided patient scan data (Images may cause misalignment, the definitive abutment will not seat in the correct orientation upon attempted placement with the patient
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Biomet 3i, LLC
- Distributor
- FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
- Lot
- Lot Numbers: 8570638-1 UDI: (01)00844868030911(10)8570638-1; 8572781-3 UDI: (01)00844868030911(10)8572781-3
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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