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.
What this means for you
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 that
- Manufacturer
- Brainlab AG
- 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
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