Recall Z-0320-2018
Brainlab AG · initiated November 16, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
Codes / lots: Model No. 19154, UDI GTIN 04056481132187. Model No. 19154-04, UDI No. GTIN 04056481113926. Serial No. range 7459316001 - 7459316027 and 7714816001 - 7714816017.
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: Nonconforming Material/Component
Action taken
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
Details
- Recall number
- Z-0320-2018
- Initiated
- November 16, 2017
- Terminated
- August 24, 2020
- Product code
- HAW – Neurological Stereotaxic Instrument
- Quantity
- 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.
- Recalling firm
- Brainlab AG, Munich