BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
Reported: October 14, 2020 Initiated: August 31, 2020 #Z-0073-2021
Product Description
BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
Reason for Recall
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
Details
- Recalling Firm
- Biomet 3i, LLC
- Units Affected
- 7 stand alone units
- Distribution
- FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA
- Location
- Palm Beach Gardens, FL
Frequently Asked Questions
What product was recalled? ▼
BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ. Recalled by Biomet 3i, LLC. Units affected: 7 stand alone units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 14, 2020. Severity: Moderate. Recall number: Z-0073-2021.
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