***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11 — Class II medical device recall Z-2158-2012
Terminated recall by Biomet 3i, LLC, reported 2012-08-15. Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant'
| Recall number | Z-2158-2012 |
|---|---|
| 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 | 2012-03-23 |
| Classified | 2012-08-08 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2013-12-16 |
| Countries outside the US | CA, FR, GB, HK, LB, MX, PL |
| Quantity | 240 |
| Lot numbers | 2011110798 |
Product
***REF IFNT611***Full OSSEOTITE Tapered Certain Implant 6 x 11.5mm***Sterile by radiation***Rx Only***BIOMET 3i Dental Iberica S.L. WTC Almeda Park, Ed, 1, Planta 1 Pl. de la Pau s/n08940 Cornella de Llobregat (Barcelona) Spain. Lot #2011110798. 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 endentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridge work and to retain over dentures.
Reason for recall
Biomet 3i is recalling their product Full Osseotite Tapered Certain Implant IFNT611. The depth of the implant's internal hex is too shallow. The condition, if present, may prevent the driver; cover screw or abutment from fully engaging the implant.
Machine access
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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.