NEODENT CM Intraoral Scanbody, Article Number: 108.139
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Product Codes/Lot Numbers:
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:
Distributed in: NJ, TX, NV, CA, PA, AZ, IL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1831-2017
Related Recalls
Product not approved for use in the US