3I OSSEOTITE CERTAIN DENTAL IMPLANTS — Class II medical device recall Z-2845-2016
Terminated recall by Biomet 3i, LLC, reported 2016-09-28, distributed in CA, FL. Product was incorrectly packaged.
| Recall number | Z-2845-2016 |
|---|---|
| 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 | 2016-08-08 |
| Classified | 2016-09-19 |
| Reported by FDA | 2016-09-28 |
| Terminated | 2019-08-06 |
| Distributed | CA, FL |
| Countries outside the US | CO, DE, ES, FR, IT |
| Quantity | 92 units |
| UPC / GTIN / UDI-DI | 00844868007098 |
| Lot numbers | 2016031461 |
| Model numbers | IOSS411 |
Product
3I OSSEOTITE CERTAIN DENTAL IMPLANTS, 4x11.5 mm, Sterile, Rx only.
Reason for recall
Product was incorrectly packaged.
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-2845-2016. 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.