FDA Device recall Z-2208-2013
Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a…
- FDA Device
- Class II
- terminated
- Published 2013-09-25
On 2013-09-25 the FDA classified a Class II recall of Osseotite Parallel Walled Certain 4mm(D)X 15mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower jaw to provide a… by Biomet 3i, citing one of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2208-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-06-10 |
| Published | 2013-09-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet 3i |
| Distribution | US |
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
One of the dental implants do not have the internal hex feature. One of the dental implants do not have the internal thread feature.
Identifiers
| code_info | IOSS415 |
|---|
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-2208-2013%22
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