Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i… — Class II medical device recall Z-0119-2013
Terminated recall by Biomet 3i, LLC, reported 2012-10-31, distributed in CT, GA, IL, KS, MA, NH, NY, OK…. Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the de
| Recall number | Z-0119-2013 |
|---|---|
| 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 | 2012-08-03 |
| Classified | 2012-10-23 |
| Reported by FDA | 2012-10-31 |
| Terminated | 2012-12-20 |
| Distributed | CT, GA, IL, KS, MA, NH, NY, OK, OR, PA, VA |
| Countries outside the US | AU, BR, DE, ES, FR, IE, IT, JP, PT, PY |
| Quantity | 227 |
| Lot numbers | 2011090751 |
| Model numbers | INT510 |
Product
Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures.
Reason for recall
Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading.
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-0119-2013. 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.