# FDA recall Z-0320-2018

> **Brainlab AG** · Class II · device recall initiated 2017-11-16.

## 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.

## Distribution

Distributed in the US to Kansas.    Distributed internationally to Australia, Finland, France, Germany, Hong Kong, Ireland, Japan, Netherlands, Norway, Sweden, Switzerland, Taiwan,  Turkey, United Kingdom.

## Key facts

- **Recall number:** Z-0320-2018
- **Recalling firm:** Brainlab AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-16
- **Report date:** 2018-01-17
- **Termination date:** 2020-08-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Munich, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0320-2018

## Citation

> AI Analytics. FDA recall Z-0320-2018. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0320-2018. Source: US FDA. Licensed CC0.

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