FDA recall Z-0320-2018

Brainlab AG · Class II · device

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

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

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