Preat Corp is recalling 44 units of its Astra EV-compatible 4.2mm Digital Analog dental tools because of a manufacturing error. The rotational feature on these devices is misaligned by 180 degrees, which can lead to the creation of incorrect dental models and ill-fitting dental prosthetics for patients. No incidents or injuries have been reported to date, and the recall involves specific models sold to dental clinics and healthcare providers.
The 180-degree misalignment in the tool's rotational feature can cause dental restorations to be fabricated in the wrong orientation. This could result in dental implants or crowns that do not fit the patient properly, requiring medical correction or the reproduction of the dental work.
Rx Only. Manufacturing error: rotational feature is 180 degrees off.
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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