Osseotite Parallel Walled Certain 4mm — Class II medical device recall Z-2208-2013
Terminated recall by Biomet 3i, LLC, reported 2013-09-25, distributed nationwide. One of the dental implants do not have the internal hex feature. One of the dental implants do not have the in
| Recall number | Z-2208-2013 |
|---|---|
| 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 | 2013-06-10 |
| Classified | 2013-09-16 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2014-11-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BR, CA, CH, DE, DO, FR, GB, IT, JP, PT, SG, TW, UY |
| Quantity | 178 |
Product
Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: 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
One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
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-2208-2013. 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.