Device product
BELLATEK TITANIUM ABUTMENT 4.1MM Reference Number: EDAT4
Z-0074-2021
Product summary
- Firm
- Biomet 3i, LLC
- Event
- Event 86402
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0074-2021
Official wording
Reason: 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
Code information: Lot Numbers: 8570638-1 UDI: (01)00844868030911(10)8570638-1; 8572781-3 UDI: (01)00844868030911(10)8572781-3
Distribution pattern: FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
Derived failure modes
-
Unknown
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