Brainlab AG: Medical Device Recall in 2018 - (Recall #: Z-0320-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 16, 2017

Date Posted: January 17, 2018

Recall Number: Z-0320-2018

Event ID: 78715

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.

Status: Terminated

Product Quantity: 80 devices total

Code Information:

Model No. 19154, UDI GTIN 04056481132187. Model No. 19154-04, UDI No. GTIN 04056481113926. Serial No. range 7459316001 - 7459316027 and 7714816001 - 7714816017.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated