BIOMET 3i Endosseous Dental Implant — Class II medical device recall Z-1458-2014
Terminated recall by Biomet 3i, LLC, reported 2014-04-23. Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental impl
| Recall number | Z-1458-2014 |
|---|---|
| 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 | 2013-08-29 |
| Classified | 2014-04-15 |
| Reported by FDA | 2014-04-23 |
| Terminated | 2014-10-17 |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CA, CH, CL, CO, CR, DE, DO, ES, FR, GB, GR, HK, IE, IL, IN, IT, JP, KR, LB, LT, MX, NL, PL, PT, PY, SA, SE, SG, TR, TW, UY, VN, ZA |
| Quantity | 34,744 |
Product
BIOMET 3i Endosseous Dental Implant.
Reason for recall
Due to residual machining fluid identified by discoloration (darker in appearance) on the external dental implant surface.
Machine access
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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.