NEODENT CM Intraoral Scanbody, Article Number: 108.139

FDA device recall Z-1831-2017 · posted 2017-04-07 · Terminated

Recall details

Recalling firm

Instradent USA, Inc.

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.

Action taken

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

Status

Terminated

Product code

NDP

Quantity affected

170 pieces

Distribution

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

Date initiated

2017-03-13

Date posted

2017-04-07

Date terminated

2019-02-28

Location

Andover, MA