FDA Enforcement
Class II
Ongoing
Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
Recall: Z-0154-2024
·
Reported November 1, 2023
Enforcement
- Recall Number
- Z-0154-2024
- Event ID
- 92867
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Preat Corp
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 1, 2023
- Initiation Date
- July 18, 2023
- Classification Date
- October 23, 2023
- Address
- 2625 Skyway Dr Ste B, N/A, Santa Maria, CA, 93455-1405, United States
Description
Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
Reason
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
Code Info
UDI-DI: 00842092161395/Lot #OF018355
Distribution
US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None
Quantity
4 units