CERTAIN BELLATEK TITANIUM ABUTMENT 6 — Class II medical device recall Z-0079-2021
Terminated recall by Biomet 3i, LLC, reported 2020-10-14, distributed in FL, GA, ID, IL, MI, NV, NY, OH…. Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees during manufacturing as compared
| Recall number | Z-0079-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet 3i, LLC, Palm Beach Gardens, FL, United States |
| Recall initiated | 2020-08-31 |
| Classified | 2020-10-08 |
| Reported by FDA | 2020-10-14 |
| Terminated | 2022-07-06 |
| Distributed | FL, GA, ID, IL, MI, NV, NY, OH, SC, TN, VA |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 00844868031208 |
| Lot numbers | 8562282-1 |
Product
CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0079-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.