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Terminated

NEODENT CM Intraoral Scanbody, Article Number: 108.139

FDA Recall Z-1831-2017 · Posted 2017-04-07

Recalling FirmInstradent USA, Inc.
Recall StatusTerminated
Product CodeNDP
Date Initiated2017-03-13
Date Terminated2019-02-28
Product Quantity170 pieces

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.

Firm 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.

Root Cause

Component design/selection

Distribution Pattern

Distributed to the states of: NJ, TX, NV, CA, PA, AZ, and IL.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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