FDA recall Z-1761-2025

Augmedics Ltd. · Class II · device

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.

Reason for recall

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

Distribution

US Nationwide.

Key facts

Status
Ongoing
Initiation date
2025-04-14
Report date
2025-05-21
Voluntary/Mandated
Voluntary: Firm initiated
Location
Yokneam Illit Northern, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1761-2025