Recall Z-1831-2017— Instradent USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Instradent USA, Inc., initiated 2017-03-13, terminated 2019-02-28. FDA's recall record names no specific 510(k) clearance for this event. Product: NEODENT CM Intraoral Scanbody, Article Number: 108.139. 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..
- Recalling firm
- Instradent USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-13
- Terminated
- 2019-02-28
- Firm location
- Andover, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.