Recall Z-1285-2023 ยท NHA Abutment, Implant, Dental, Endosseous
Preat Corp
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
| Date | Mar 24, 2023 (initiated Feb 21, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Process design |
| 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 |
| Quantity | 26 |
| Distribution | US Nationwide distribution in the states of TX, OR, UT, NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220823 | Preat Abutments Preat Corporation, Oct 26, 2022 |