Agency classClass IIOur severity:High FDA (Devices)·Z-0967-2014·Announced 2014-02-19

Brainlab VectorVision Spine Instrument Star Unit ML Recall

Brainlab is recalling 25 VectorVision Spine Instrument Star Unit ML devices because pins may be made of incorrect material, posing a risk of corrosion and particle release during surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device where a material defect could lead to particle release during surgery, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Brainlab AG is recalling 25 units of the VectorVision Spine Instrument Star Unit ML (Model/Catalog Code: 55830-25A). The recall is due to a determination that pins in the Instrument Star Unit ML (Calibration with ICM4) with specific serial numbers might have been made of an incorrect material. This material is not suitable for the necessary disinfection and sterilization of the product.

The affected devices are intended for use as an intraoperative image-guided localization system for minimally invasive surgery. The system links a freehand probe, tracked by a passive marker sensor system, to virtual computer image space on a patient's preoperative image data. The recall covers devices distributed worldwide, including in the United States (CA, MN, NC, NY, OH, TX, and DC) and internationally to Australia, Chile, Germany, Hungary, Italy, Panama, Qatar, Russia, Thailand, and the United Arab Emirates.

If corrosion occurs on the pins and is not detected by the user, and the device is used during surgery, corroded particles of the pin could be released directly or indirectly. Users should stop using the affected devices and contact Brainlab AG for further instructions.

The recalled product

Product: 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…
Manufacturer: Brainlab AG
Category: Medical Device — Surgical Instrument
Hazard: corrosion
particle-release
Affected units: 25

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

Distribution

Distributed in 7 states:

Same manufacturer · Brainlab AG

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Same hazard · corrosion