Brainlab Navigation System Spine & Trauma 3D with component Brainlab… — Class II medical device recall Z-0320-2018
Terminated recall by Brainlab AG, reported 2018-01-17, distributed in KS. Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainla
| Recall number | Z-0320-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Munich, N/A, Germany |
| Recall initiated | 2017-11-16 |
| Classified | 2018-01-05 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2020-08-24 |
| Distributed | KS |
| Countries outside the US | AU, CH, DE, FI, FR, GB, HK, IE, JP, NL, NO, SE, TR, TW |
| Quantity | 80 devices |
| UPC / GTIN / UDI-DI | 04056481113926, 04056481132187 |
| Model numbers | 19154, 19154-04 |
Product
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
Reason for recall
Due to a human error at a supplier, an unknown number of devices within one specific production lot of Brainlab DrapeLink Adapters (Left/Right) were not manufactured according to defined specifications.
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-0320-2018. 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.