Recall Z-1285-2023— Preat Corp
Class II · Ongoing
Class II FDA medical device recall by Preat Corp, initiated 2023-02-21. It names one FDA 510(k) clearance: K220823. Product: Neodent GM X 6mm Engaging Titanium Base, REF: 9007162. 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..
- Recalling firm
- Preat Corp
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-21
- Firm location
- Santa Maria, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.