Food, drugs, devices › Preat Corp
Device recall: Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
FDA enforcement event 92867 is a device recall by Preat Corp of Santa Maria, CA, initiated 18 Jul 2023 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Preat Corp has 9 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Preat Corp, Santa Maria, CA.
Reason for recall
"The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage"
Distribution
"US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0152-2024 | Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental | 13 units | Class II | Ongoing | 1 Nov 2023 |
| Z-0153-2024 | Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental | 23 units | Class II | Ongoing | 1 Nov 2023 |
| Z-0154-2024 | Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental | 4 units | Class II | Ongoing | 1 Nov 2023 |
Context
Other enforcement events for Preat Corp
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.