Z-0320-2018Class II

Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm...

Name: Z-0320-2018 Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm...
Creator: Brainlab AG
Published: 2017-11-16
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2017-11-16 / Terminated / root cause: manufacturing process

FDA source

Brainlab AG began a recall of Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left on 2017-11-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0320-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-16
Posted: 2018-01-05
Terminated: 2020-08-24
Recalling firm: Brainlab, Inc.
Product: Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Customers were notified, via email on approximately 11/16/2017. Instructions included to identify all affected devices on hand, cease use of the affected device, and a Brainlab Customer Support Representative will contact the customer to arrange a service visit to replace the item
Quantity in commerce: 80 devices total
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.
Product codes and lots: Model No. 19154, UDI GTIN 04056481132187. Model No. 19154-04, UDI No. GTIN 04056481113926. Serial No. range 7459316001 - 7459316027 and 7714816001 - 7714816017.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0320-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0320-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-17	2018-01-05

Product code HAW

K070106Class IIVv Fluoro 3DBrainlab AG / cleared 2007-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)