NEODENT CM Intraoral Scanbody — Class II medical device recall Z-1831-2017
Terminated recall by Instradent USA, Inc., reported 2017-04-26, distributed in AZ, CA, IL, NJ, NV, PA, TX. During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Int
| Recall number | Z-1831-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instradent USA, Inc., Andover, MA, United States |
| Recall initiated | 2017-03-13 |
| Classified | 2017-04-17 |
| Reported by FDA | 2017-04-26 |
| Terminated | 2019-02-28 |
| Distributed | AZ, CA, IL, NJ, NV, PA, TX |
| Quantity | 170 units |
| Lot numbers | 56.390, 63.224, 71.065, 71.066, 71.067, 71.068, 71.069, 71.070, 800.214.016, 800.217.067 |
Product
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Reason for recall
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.
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-1831-2017. 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.