NEODENT CM Intraoral Scanbody recall
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Why was NEODENT CM Intraoral Scanbody recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- NEODENT CM Intraoral Scanbody, Article Number: 108.139
- Recalling firm
- Instradent USA, Inc.
- Quantity
- 170 pieces
- Distribution
- Distributed to the states of: NJ, TX, NV, CA, PA, AZ, and IL.
- Recall date
- April 26, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)