FDA Device recall Z-1215-2014
Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTe…
- FDA Device
- Class II
- terminated
- Published 2014-03-26
On 2014-03-26 the FDA classified a Class II recall of Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTe… by Biomet 3i, citing reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1215-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-26 |
| Published | 2014-03-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet 3i |
| Distribution | US |
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
Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.
Identifiers
| code_info | All lots of products made since April 1, 2011. Catalog model EDAZ, EDAZx and ILDExxx |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1215-2014%22
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