Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1831-2017 — NEODENT CM Intraoral Scanbody, Article Number: 108.139

U.S. FDA — Device Enforcement · United States · 2017-03-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1831-2017
Date of alert
2017-03-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Instradent USA, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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