Recall Z-0320-2018— Brainlab AG
Class II · Terminated
Class II FDA medical device recall by Brainlab AG, initiated 2017-11-16, terminated 2020-08-24. It names one FDA 510(k) clearance: K070106. Product: Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left. Reason: 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..
- Recalling firm
- Brainlab AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-16
- Terminated
- 2020-08-24
- Firm location
- Munich, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.