Z-1761-2025Class II

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

Name: Z-1761-2025 Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an...
Creator: Augmedics Ltd.
Published: 2025-04-14
License: https://open.fda.gov/license/

Augmedics Ltd. / initiated 2025-04-14 / Open, Classified / root cause: design

FDA source

Augmedics Ltd. began a recall of Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed... on 2025-04-14. FDA classified it as Class II and gives the reason as "The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1761-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-14
Posted: 2025-05-13
Recalling firm: Augmedics Ltd.
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.
Product code: OLO Orthopedic Stereotaxic Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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]
Quantity in commerce: 85 units
Distribution: US Nationwide.
Product codes and lots: UDI: 07290113780910; Lot Numbers: 038110 to 054926

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1761-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1761-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-13

Product code OLO

K211188Class IIxvision Spine system (XVS)Augmedics, Ltd. / cleared 2021-07-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)