Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200… recallZ-1761-2025 · Augmedics Ltd. · initiated Apr 14, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Augmedics Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
FDA root cause category: Device Design
What the company is doing
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: [email protected]
Recall details
- Recall number
- Z-1761-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 14, 2025
- Posted by the FDA
- May 13, 2025
- Recalling firm
- Augmedics Ltd.
- Quantity
- 85 units
- Product code
- OLO
- FDA submissions
- K211188
- Distribution
- US Nationwide.
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.
Code information (models, lots, serial numbers)
UDI: 07290113780910; Lot Numbers: 038110 to 054926
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Perc Pin Adaptor AMCH07200Augmedics Ltd · Orthopedic Augmented Reality1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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