Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
FDA Recall Z-1285-2023 · Posted 2023-03-24
Recalling FirmPreat Corp
Recall StatusOpen, Classified
Product CodeNHA
Date Initiated2023-02-21
Product Quantity26
Reason for Recall
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.
Firm Action
On 2/21/23, recall notices were mailed to customers who were asked to discard or return affected devices to the recalling firm. In addition, in the event affected product was further distributed, customers were asked to inform their customers, or to provide a customer list so the recalling firm could notify these additional customers. The customer service number was provided: 800-232-7732
Root Cause
Process design
Distribution Pattern
US Nationwide distribution in the states of TX, OR, UT, NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.