Data Foundry

Medical device recalls 2023

Preat REF 9007124 — Class II medical device recall Z-0154-2024

Ongoing recall by Preat Corp, reported 2023-11-01, distributed in CA, FL, NJ, OH, OR, SC, TX. The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and

Recall numberZ-0154-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPreat Corp, Santa Maria, CA, United States
Recall initiated2023-07-18
Classified2023-10-23
Reported by FDA2023-11-01
DistributedCA, FL, NJ, OH, OR, SC, TX
Quantity4 units
UPC / GTIN / UDI-DI00842092161395
Lot numbersOF018355
Model numbers9007124

Product

Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0154-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.