Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach… — Class II medical device recall Z-1215-2014
Terminated recall by Biomet 3i, LLC, reported 2014-03-26, distributed nationwide. Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.
| Recall number | Z-1215-2014 |
|---|---|
| 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 | 2013-08-26 |
| Classified | 2014-03-17 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2014-09-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CH, CO, CZ, DE, DK, EE, ES, FR, GB, IE, IT, JP, LU, MX, NL, NO, PL, PT, SE, UY |
| Quantity | 10,454 |
| Reason classes | device malfunction |
Product
Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to use.***Biomet 3i Dental Iberica S.L.*** Biomet 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients. These are intended for use to support single and multiple tooth prostheses.
Reason for recall
Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.
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-1215-2014. 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.