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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 3D see related information
Date Initiated by Firm November 16, 2017
Create Date January 05, 2018
Recall Status1 Terminated 3 on August 24, 2020
Recall Number Z-0320-2018
Recall Event ID 78715
510(K)Number K070106  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product Brainlab 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.
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
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HAW and Original Applicant = BRAINLAB AG
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