medical Class II Updated 2025-05-21

Augmedics Ltd. recalls Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200,

Recalled Product

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.


Hazard / Issue

The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 07290113780910; Lot Numbers: 038110 to 054926
View official government recall

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