FDAFDA · Food and drugs·Recall number Z-1831-2017
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Published April 26, 2017 · Recall initiated: March 13, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Instradent USA, Inc.
- Distributor
- Distributed to the states of: NJ, TX, NV, CA, PA, AZ, and IL.
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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