Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported April 26, 2017
NEODENT CM Intraoral Scanbody, Article Number: 108.139
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Instradent USA, Inc. recalled NEODENT CM Intraoral Scanbody, Article Number: 108.139 - a moderate-severity action.
NEODENT CM Intraoral Scanbody, Article Number: 108.139 was recalled by Instradent USA, Inc. in April 26, 2017. Reason: During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact In…. Check the official notice for the remedy. Verify recall #Z-1831-2017 with the FDA Devices before acting.
The recall
Instradent USA, Inc. issued this moderate-severity FDA Devices recall-During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact In….
- Moderate
- severity level
- Class II
- classification
- April 26, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1831-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1831-2017) was formally reported on April 26, 2017, with the manufacturer initiating the action on March 13, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Instradent USA, Inc. is listed as the recalling firm, operating out of Andover, MA. Federal records list the affected scope as 170 pieces.
The documented reason for this recall is: 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 intraosseous… Distribution data in the federal record shows the product reached: Distributed to the states of: NJ, TX, NV, CA, PA, AZ, and IL.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
170 pieces
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1831-2017 |
| Date reported | April 26, 2017 |
| Date initiated | March 13, 2017 |
| Recalling firm | Instradent USA, Inc. |
| Firm location | Andover, MA |
| Affected scope | 170 pieces |
| Distribution | Distributed to the states of: NJ, TX, NV, CA, PA, AZ, and IL. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1831-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
NEODENT CM Intraoral Scanbody, Article Number: 108.139. Recalled by Instradent USA, Inc.. Units affected: 170 pieces.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 26, 2017. Severity: Moderate. Recall number: Z-1831-2017.
Where was the recalled product distributed? ▼
Distribution: Distributed to the states of: NJ, TX, NV, CA, PA, AZ, and IL..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1831-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 26, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.