Brainlab AG recalls Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision…

Recall date

November 16, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0320-2018

FDA classification

Class II

Brand / firm

Brainlab AG

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left