Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
- Company
- Preat Corp
- Recall Initiated
- February 21, 2023
- Posted
- March 24, 2023
- Recall Number
- Z-1285-2023
- Quantity
- 26
- Firm Location
- Santa Maria, CA
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.
Distribution
US Nationwide distribution in the states of TX, OR, UT, NY.
Lot / Code Info
UDI: 00842092161326, Lots: 211891 and 211912
Root Cause
Process design
Action Taken
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