FDA Device recall Z-0298-2013
Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411
- FDA Device
- Class II
- terminated
- Published 2012-11-28
On 2012-11-28 the FDA classified a Class II recall of Product is Full OSSEOTITE Parallel Walled Certain Implant, Model Number IFOA411 by Biomet 3i, citing 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 in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0298-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-28 |
| Published | 2012-11-28 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet 3i |
| Distribution | US |
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
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.
Identifiers
| code_info | Model Number IFOA411, Lot # 2011111333, 2011111333-S1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0298-2013%22
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