Recall Z-1761-2025— Augmedics Ltd.

Name: FDA recall Z-1761-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-14

Class II · Ongoing

Class II FDA medical device recall by Augmedics Ltd., initiated 2025-04-14. It names one FDA 510(k) clearance: K211188. 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: The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed..

Recalling firm: Augmedics Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2025-04-14
Firm location: Yokneam Illit Northern, Israel

510(k) clearances named in this recall

1 on FDA's record

K211188 — xvision Spine system (XVS)Augmedics, Ltd.·cleared 2021-07-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.