FDA-Device2025-05-21Class II
Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery.
Augmedics Ltd.
Hazard
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
Sold states
US Nationwide.
Affected count
85 units
Manufactured in
2 Ha-Otsma St, Yokneam Illit Northern, Israel
Products
Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1761-2025Don't want to check this manually?
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