Multiple Digital Analog Products labeled as: NobelBiocare… — Class II medical device recall Z-2687-2024
Ongoing recall by Preat Corp, reported 2024-08-28, distributed nationwide. Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to vi
| Recall number | Z-2687-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Preat Corp, Santa Maria, CA, United States |
| Recall initiated | 2024-06-25 |
| Classified | 2024-08-19 |
| Reported by FDA | 2024-08-28 |
| Distributed | Nationwide (US) |
| Quantity | 185 devices |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00842092178690, 00842092178737, 00842092178775, 00842092178812, 00842092178898, 00842092178928, 00842092178959, 00842092178997, 00842092181898, 00842092181959, 00842092182130 |
| Lot numbers | 248890, 249071, 249510, 250213, 250215, 250219, 250223, 250335, 250336, 250418, 250602, 251432, 251459 |
| Model numbers | 3.0MM, 3.5MM, 5.0MM, 5.7MM, 6.0MM, 9000703, 9001303, 9001903, 9002003, 9002103, 9002203, 9005203, 9005303, 9005403, 9005503, 9006767, 9008503 |
Product
Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog, REF 9002003 Astra-compatible 3.0mm Digital Analog, REF 9002103 Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203 Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203 BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203 Legacy-compatible 3.0mm Digital Analog, REF 9005303 Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403 Legacy-compatible 3.5mm Digital Analog, REF 9005503 Legacy-compatible 5.7mm Digital Analog, REF 9008503 Astra EV 4.8mm Milled Titanium Abutment REF 9006767 Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory.
Reason for recall
Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations.
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-2687-2024. 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.