Z-1831-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 26, 2017
- Initiation Date
- March 13, 2017
- Termination Date
- February 28, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 170 pieces
Product Description
NEODENT CM Intraoral Scanbody, Article Number: 108.139
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.
Distribution Pattern
Distributed to the states of: NJ, TX, NV, CA, PA, AZ, and IL.
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.