FDA Device recall Z-1831-2017
NEODENT CM Intraoral Scanbody, Article Number: 108.139
- FDA Device
- Class II
- terminated
- Published 2017-04-26
On 2017-04-26 the FDA classified a Class II recall of NEODENT CM Intraoral Scanbody, Article Number: 108.139 by Instradent Usa, citing during internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the platform diameter of CM I….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1831-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-13 |
| Published | 2017-04-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Instradent Usa |
| Distribution | AZ, CA, IL, NJ, NV, PA, TX |
Product
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Reason
During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the platform diameter of CM Implants when the implant is intraosseoussly (subcrestally) positioned.
Identifiers
| code_info | Lot Numbers: 800.214.016, 800.217.067, 56.390, 63.224, 71.065, 71.066, 71.067, 71.068, 71.069, and 71.070. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1831-2017%22
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