FDA Device recall Z-0073-2021
BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
- FDA Device
- Class II
- terminated
- Published 2020-10-14
On 2020-10-14 the FDA classified a Class II recall of BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ by Biomet 3i, citing 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, t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0073-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-08-31 |
| Published | 2020-10-14 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Biomet 3i |
| Distribution | FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA |
Product
BellaTek Encode Defin3DPMSERitive Abutments-3D Printed Model Reference Numbers: 3DPMSER, 3DPMSERQ
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
Identifiers
| code_info | Reference Number: 3DPMSER Lot Numbers: 8560249-1 8564285-1 8570989-1 Reference Number: 3DPMSERQ Lot Numbers: 8561588-1 8561591-1 8569150-1 8570607-1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0073-2021%22
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