Recall Z-1831-2017 ยท NDP Accessories, Implant, Dental, Endosseous
Instradent USA, Inc.
NEODENT CM Intraoral Scanbody, Article Number: 108.139
| Date | Apr 7, 2017 (initiated Mar 13, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | Instradent sent an Urgent Field Safety Notice dated March 13, 2017, to all affected customers via UPS. Customers were asked to take the following actions: 1. Identify and segregate the affected units from your stock. 2. If the product is still in your Inventory, return it for credit. 3. If you have used the product successfully, there is no need to take any action 4. For all cases complete and return the enclosed Customer Confirmation Form. For further questions, please call (855) 412-8883. |
| Quantity | 170 pieces |
| Distribution | Distributed to the states of: NJ, TX, NV, CA, PA, AZ, and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.