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Recall Observatory FDA recall evidence

Device product

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

Z-1285-2023

February 21, 2023

Class II

Product summary

Firm
Preat Corp
Event
Event 91876
Status
Ongoing
Classification
Class II
Quantity
26
Official record key
device-enforcement:Z-1285-2023

Official wording

Reason: Engaging 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.

Code information: UDI: 00842092161326, Lots: 211891 and 211912

Distribution pattern: US Nationwide distribution in the states of TX, OR, UT, NY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Engaging 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.