Z-1831-2017Class II

NEODENT CM Intraoral Scanbody, Article Number: 108.139

Name: Z-1831-2017 NEODENT CM Intraoral Scanbody, Article Number: 108.139
Creator: Instradent USA, Inc.
Published: 2017-03-13
License: https://open.fda.gov/license/

Straumann USA, LLC / initiated 2017-03-13 / Terminated / root cause: design

FDA source

Instradent USA, Inc. began a recall of NEODENT CM Intraoral Scanbody, Article Number: 108.139 on 2017-03-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1831-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-13
Posted: 2017-04-07
Terminated: 2019-02-28
Recalling firm: Straumann USA, LLC
Product: NEODENT CM Intraoral Scanbody, Article Number: 108.139
Product code: NDP Accessories, Implant, Dental, Endosseous
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: Instradent sent an Urgent Field Safety Notice dated March 13, 2017, to all affected customers via UPS. Customers were asked to take the following actions: 1. Identify and segregate the affected units from your stock. 2. If the product is still in your Inventory, return it for credit. 3. If you have used the product successfully, there is no need to take any action 4. For all cases complete and return the enclosed Customer Confirmation Form. For further questions, please call (855) 412-8883.
Quantity in commerce: 170 pieces
Distribution: Distributed to the states of: NJ, TX, NV, CA, PA, AZ, and IL.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1831-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1831-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-17

Product code NDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)