Reported Nov 1, 2023 · Ongoing
Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
Preat Corp.
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: Preat Corp · 2625 Skyway Dr Ste B · Santa Maria, CA · 93455-1405
Is this the product you have?
- Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
- Lot codes and dates
- UDI-DI00842092161395/Lot #OF018355
- Amount recalled
- 4 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
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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