Brainlab AG: Medical Device Recall in 2014 - (Recall #: Z-0967-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatomy.

Product Classification:

Class II

Date Initiated: November 15, 2013

Date Posted: February 19, 2014

Recall Number: Z-0967-2014

Event ID: 67017

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

Status: Terminated

Product Quantity: 25 units

Code Information:

Model/Catalog Code: 55830-25A Instrument Star Unit ML; Serial Numbers (US Devices): 1205112007, 1205112010, 1205112011, 1205112013, 1205112014, 1205112019, 1205112021, 1205112029, 1205112034, 1205112045; Serial Numbers (Non-US Devices): 1205112004, 1205112006, 1205112008, 1205112009, 1205112015, 1205112016, 1205112017, 1205112018, 1205112020, 1205112023, 1205112025, 1205112026, 1205112027, 1205112030, 1205112032

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated