Neodent CM Intraoral Scanbody Recalled for Incompatibility with CM Implants
Instradent USA is recalling 170 Neodent CM Intraoral Scanbodies because the body diameter is incompatible with CM Implants when positioned subcrestally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving a functional incompatibility defect. The source text does not report any injuries, illnesses, or hospitalizations, and the hazard is limited to mechanical fit issues rather than direct biological harm.
Plain-English summary
Instradent USA, Inc. is recalling 170 pieces of the NEODENT CM Intraoral Scanbody, Article Number 108.139. The affected units were distributed to the states of New Jersey, Texas, Nevada, California, Pennsylvania, Arizona, and Illinois. The specific lot numbers involved are 800.214.016, 800.217.067, 56.390, 63.224, 71.065, 71.066, 71.067, 71.068, 71.069, and 71.070.
The recall was initiated after internal testing determined that the body diameter of the scanbody (3.8mm) is not compatible with the platform diameter of CM Implants when the implant is positioned intraosseously (subcrestally). This incompatibility may prevent proper fit or function in specific clinical configurations.
Healthcare professionals and patients who have used or possess these specific scanbodies should contact Instradent USA, Inc. for further instructions on how to proceed. The source text does not report any illnesses, injuries, or adverse health consequences associated with this recall.
The recalled product
- Product
- NEODENT CM Intraoral Scanbody, Article Number: 108.139
- Manufacturer
- Instradent USA, Inc.
- Affected units
- 170
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- 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
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