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Terminated

Brainlab Navigation System Spine & Trauma 3D with component Brainlab DrapeLink Registration Kit for C-arm Zeihm Vision RFD: Adapter Left

FDA Recall Z-0320-2018 · Posted None

Recalling FirmBrainlab AG
Recall StatusTerminated
Product CodeHAW
Date Initiated2017-11-16
Date Terminated2020-08-24
Product Quantity80 devices total

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.

Firm 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

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070106VV FLUORO 3DBrainlab AG · 2007-04-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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