Z-1285-2023 Class II Ongoing
FDA device recall Z-1285-2023 was initiated by Preat Corp on February 21, 2023 and is designated Class II. 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 insta… The recall status is ongoing. Affected quantity: 26.
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2023
- Initiation Date
- February 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26
Product Description
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
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 Pattern
US Nationwide distribution in the states of TX, OR, UT, NY.
Code Information
UDI: 00842092161326, Lots: 211891 and 211912