CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM — Class II medical device recall Z-1382-2020
Terminated recall by Biomet 3i, LLC, reported 2020-03-04, distributed nationwide. Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotat
| Recall number | Z-1382-2020 |
|---|---|
| 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 | 2020-01-10 |
| Classified | 2020-02-26 |
| Reported by FDA | 2020-03-04 |
| Terminated | 2021-08-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CN, DE, ES, FR, GB, IT, JP, NL, PL |
| Lot numbers | 1228597, 1228828, 1230625 |
Product
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 3MM(H) Reference Number: IEHA553
Reason for recall
Resulting impression or scanned data produced from the Healing Abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment
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-1382-2020. 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.