Reported Apr 26, 2017 · Terminated
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Instradent USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Instradent USA, Inc. · 60 Minuteman Rd · Andover, MA · 01810-1008
Is this the product you have?
- NEODENT CM Intraoral Scanbody
- Article Number108.139
- Lot codes and dates
- Lot Numbers
800.214.016800.217.06756.39063.22471.06571.06671.06771.06871.069and 71.070
- Lot Numbers
- Amount recalled
- 170 pieces
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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