Augmedics Ltd. recalls Augmedics Perc Pin Adaptor

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

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.

A Customer Notification Letter was sent to customers beginning 4/14/25. Actions to be taken by the Customer/User. Augmedics has upgraded the Perc pin adaptor (AMCH07200) to a new design (AMCH07300). Based on user feedback, Augmedics decided to initiate a recall of the legacy units by removing the legacy units from the site and replace them with the upgraded design. Please acknowledge receipt of this notification by signing the Customer Notification Acknowledgement attached to this notification or by sending an email to Augmedics stating you have received the notification. Type of Action by the Company: "The customer is notified to stop using Perc pin adaptor AMCH07200 at the site, identified by their UDI: 07290113780910. "Augmedics representative shall remove all the affected parts (AMCH07200) from the site. "Augmedics representative shall notify the customer and provide this document to the site representative. "Augmedics representative shall provide the customer with replacement Perc pin adaptors of an updated design (AMCH07300). "Augmedics shall collect the signed Customer Notification Acknowledgement as evidence for customer notification. Contact Information: Address: Augmedics Inc. 21 S. Evergreen Ave Suite 230 Arlington Heights, IL 60005 Email: Customerservice@augmedics.com

• FDA enforcement recordOfficial FDA database entry for Z-1761-2025
• FDA 510(k) clearance · K211188The device's official FDA premarket clearance record
• FDA device classification · OLOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.4560The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Augmedics Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.