Instradent USA, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1831-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

NEODENT CM Intraoral Scanbody, Article Number: 108.139

Product Classification:

Class II

Date Initiated: March 13, 2017

Date Posted: April 26, 2017

Recall Number: Z-1831-2017

Event ID: 76843

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.

Status: Terminated

Product Quantity: 170 pieces

Code Information:

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated