Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guid

FDA device recall Z-1761-2025 · posted 2025-05-13 · Open, Classified

Recall details

Recalling firm

Augmedics Ltd.

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.

Action taken

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

Root cause

Device Design

Status

Open, Classified

Product code

OLO

Quantity affected

85 units

Distribution

US Nationwide.

Date initiated

2025-04-14

Date posted

2025-05-13

Location

Illit, Northern, Israel

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