BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing… — Class II medical device recall Z-2594-2014
Terminated recall by Biomet 3i, LLC, reported 2014-09-17, distributed in NH, TX. Identifiers on the label are correct but the label has the incorrect color coding.
| Recall number | Z-2594-2014 |
|---|---|
| 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 | 2014-06-25 |
| Classified | 2014-09-05 |
| Reported by FDA | 2014-09-17 |
| Terminated | 2014-09-23 |
| Distributed | NH, TX |
| Quantity | 6 units |
| Reason classes | labeling |
| Lot numbers | 1167545 |
| Model numbers | IEHA458 |
Product
BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
Reason for recall
Identifiers on the label are correct but the label has the incorrect color coding.
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-2594-2014. 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.