Preat Corp Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Brand
Preat Corp
Lot Codes / Batch Numbers
UDI: 00842092161326, Lots: 211891 and 211912
Products Sold
UDI: 00842092161326, Lots: 211891 and 211912
Preat Corp is recalling Neodent GM X 6mm Engaging Titanium Base, REF: 9007162 due to Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026