Z-1831-2017 Class II Terminated
FDA device recall Z-1831-2017 was initiated by Instradent USA, Inc. on March 13, 2017 and is designated Class II. 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 impl… The recall status is terminated (terminated February 28, 2019). Affected quantity: 170 pieces.
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.