Z-0320-2018 Class II Terminated
FDA device recall Z-0320-2018 was initiated by Brainlab AG on November 16, 2017 and is designated Class II. 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 specificatio… The recall status is terminated (terminated August 24, 2020). Affected quantity: 80 devices total.
Recall Details
- Product Type
- Devices
- Report Date
- January 17, 2018
- Initiation Date
- November 16, 2017
- Termination Date
- August 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 80 devices total
Product Description
Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left
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.
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.
Code Information
Model No. 19154, UDI GTIN 04056481132187. Model No. 19154-04, UDI No. GTIN 04056481113926. Serial No. range 7459316001 - 7459316027 and 7714816001 - 7714816017.