NEODENT CM Intraoral Scanbody, Article Number: 108.139

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 indicate 170 pieces units are affected.

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.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 9 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.