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U.S. Department of Health and Human Services

Class 2 Device Recall Brainlab Navigation System Spine & Trauma 3D

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 Class 2 Device Recall Brainlab Navigation System Spine & Trauma 3Dsee related information
Date Initiated by FirmNovember 16, 2017
Create DateJanuary 05, 2018
Recall Status1 Terminated 3 on August 24, 2020
Recall NumberZ-0320-2018
Recall Event ID 78715
510(K)NumberK070106 
Product Classification Neurological stereotaxic Instrument - Product Code HAW
ProductBrainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
Code Information Model No. 19154, UDI GTIN 04056481132187. Model No. 19154-04, UDI No. GTIN 04056481113926. Serial No. range 7459316001 - 7459316027 and 7714816001 - 7714816017.
FEI Number 3002619595
Recalling Firm/
Manufacturer		 Brainlab AG
Olof-Palme-Strasse 9
Munich Germany
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionCustomers 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 Commerce80 devices total
DistributionDistributed in the US to Kansas. Distributed internationally to Australia, Finland, France, Germany, Hong Kong, Ireland, Japan, Netherlands, Norway, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HAW
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