Augmedics Ltd. recalls Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-gui…

Recall date

April 14, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1761-2025

FDA classification

Class II

Brand / firm

Augmedics Ltd.

Sold / distributed

US Nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.