FDA Device recall Z-0152-2024
Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only
- FDA Device
- Class II
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class II recall of Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only by Preat, citing the healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0152-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-18 |
| Published | 2023-11-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Preat |
| Distribution | CA, FL, NJ, OH, OR, SC, TX |
Product
Preat REF 9007121, Neodent GM x 2mm Healing Abutment, 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
Identifiers
| code_info | UDI-DI: 00842092161364/Lot # OF018356 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0152-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.