FDAApril 14, 2025device

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 recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

augmedics

UPCs

07290113780910

Recall history

No related federal recalls on record for this brand yet.

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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. — Recall Details · AllClear