Preat Corp is recalling 40 units of Neodent GM Healing Abutments, which are dental components used during the healing phase of dental implants. These products, including the 2mm, 4mm, and 4mm Wide models, were manufactured with a dimensional error that creates a gap between the abutment and the implant. This defect allows for microleakage, which can lead to bacterial contamination or infection at the implant site. These medical devices were distributed in several U.S. states and are intended for single-use only by dental professionals.
The dimensional defect creates an improper seal between the healing abutment and the dental implant, allowing oral fluids and bacteria to leak into the implant connection. This 'microleakage' increases the risk of inflammation, tissue irritation, or infection around the implant site during the healing process.
Manufacturer notification and coordination with healthcare providers
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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