Product Safety Recalls

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Preat Corp Recall 91876

Description: Neodent GM X 6mm Engaging Titanium Base, REF: 9007162

Preat Corp Recall 91876 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1285-2023
Event ID91876
Event DescriptionNeodent GM X 6mm Engaging Titanium Base, REF: 9007162
Product TypeDevices
DistributionUS Nationwide distribution in the states of TX, OR, UT, NY.
Recall ReasonEngaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.
Device Classification20230405
Device Code InfoUDI: 00842092161326, Lots: 211891 and 211912
Center Classification Date20230324
Recall Initiation Date20230221
Recalling FirmPreat Corp
Initial Notification Letter
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