BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally in

FDA device recall Z-0967-2014 · posted 2014-02-10 · Terminated

Recall details

Recalling firm

Brainlab AG

Reason for recall

Brainlab has determined that pins of thee Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material that is not suitable for the necessary disinfection and sterilization of the product. If corrosion occurs and is not detected by the user, and the device is used during surgery, corroded particles of the pin could, directly or indirect

Action taken

BrainLab send a A FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letter dated November 15, 2013, to all affected customers. The letter requested that customers verify that they are in possession of one or more of the affected devices, remove the affected devices from use, and that Brainlab will provide replacement parts for the customers. Customers with questions can contact Brainlab by telephone at 1-800-597-5911 or via e-mail at us.support@brainlab.com. For questions regarding this recall call 800-597-5911.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HAW

Quantity affected

25 units

Distribution

Worldwide Distribution - USA including CA, MN, NC, NY, OH, TX and DC. Internationally to Australia, Chile, Germany, Hungary, Italy, Panama, Qatar, Russia, Thailand, United Arab Emirates.

Date initiated

2013-11-15

Date posted

2014-02-10

Date terminated

2017-03-13

Location

Feldkirchen, Germany

Related 510(k) clearances