Product is Full OSSEOTITE Parallel Walled Certain Implant — Class II medical device recall Z-0298-2013
Terminated recall by Biomet 3i, LLC, reported 2012-11-28, distributed nationwide. Biomet 3i recalled Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant
| Recall number | Z-0298-2013 |
|---|---|
| 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 | 2012-09-28 |
| Classified | 2012-11-16 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2015-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, DE, ES, FR, GB, HK, IE, IL, JP, NL, PL, SG, TW |
| Quantity | 76 devices |
| Lot numbers | 2011111333, 2011111333-S1 |
| Model numbers | IFOA411 |
Product
Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411. The product is sterile. Product provides 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 Full OSSEOTITE 2 Tapered Certain Implant and Full OSSEOTITE Parallel Walled Certain Implant due to a manufacturing condition where the depth of the implant's internal hex is too shallow. This condition may prevent the driver or abutment from fully engaging in the implant.
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-0298-2013. 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.