Recall Z-1761-2025 ยท OLO Orthopedic Stereotaxic Instrument
Augmedics Ltd.
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.
| Date | May 13, 2025 (initiated Apr 14, 2025) |
| Status | Open, Classified |
| 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. |
| 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 |
| Quantity | 85 units |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211188 | xvision Spine system (XVS) Augmedics, Ltd., Jul 19, 2021 |