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Recall Observatory FDA recall evidence

Device product

NEODENT CM Intraoral Scanbody, Article Number: 108.139

Z-1831-2017

March 13, 2017

Class II

Product summary

Firm
Instradent USA, Inc.
Event
Event 76843
Status
Terminated
Classification
Class II
Quantity
170 pieces
Official record key
device-enforcement:Z-1831-2017

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.