FDA Device recall Z-2512-2016
Certain Bellatek Encode Healing Abutment Dental implants
- FDA Device
- Class II
- terminated
- Published 2016-08-24
On 2016-08-24 the FDA classified a Class II recall of Certain Bellatek Encode Healing Abutment Dental implants by Biomet 3i, citing pouches may not have been sealed during packing.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2512-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-25 |
| Published | 2016-08-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomet 3i |
| Distribution | US |
Product
Certain Bellatek Encode Healing Abutment Dental implants
Reason
Pouches may not have been sealed during packing.
Identifiers
| code_info | Items: IEHA343, IEHA344, IEHA346, IEHA348, IEHA353, IEHA354, IEHA356, IEHA358, IEHA443, IEHA444, IEHA446, IEHA448, I…Items: IEHA343, IEHA344, IEHA346, IEHA348, IEHA353, IEHA354, IEHA356, IEHA358, IEHA443, IEHA444, IEHA446, IEHA448, IEHA453, IEHA454, IEHA456, IEHA458, IEHA463, IEHA464, IEHA466, IEHA468, IEHA473, IEHA474, IEHA476, IEHA478, IEHA553, IEHA554, IEHA556, IEHA558, IEHA563, IEHA564, IEHA566, IEHA568, IEHA573, IEHA574, IEHA576. IEHA578, IEHA663, IEHA664, IEHA666, IEHA668, IEHA673, IEHA674, IEHA676 and IEHA678. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2512-2016%22
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