3i T3 Non-Platform Switched Tapered Implant Rx Only — Class II medical device recall Z-1409-2015
Terminated recall by Biomet 3i, LLC, reported 2015-04-22, distributed nationwide. Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
| Recall number | Z-1409-2015 |
|---|---|
| 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 | 2014-11-07 |
| Classified | 2015-04-10 |
| Reported by FDA | 2015-04-22 |
| Terminated | 2015-05-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, DE, ES, FR, GB, IT, JP, NL, NZ, PT, TR, TW |
| Quantity | 620 implants |
| Lot numbers | 2014051395, 2014051817 |
| Expiration dates | 2018-12-09, 2018-12-11 |
Product
3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.
Reason for recall
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
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-1409-2015. 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.