Device 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.
Z-1761-2025
Product summary
- Firm
- Augmedics Ltd.
- Event
- Event 96686
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 85 units
- Official record key
device-enforcement:Z-1761-2025
Official wording
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.
Code information: UDI: 07290113780910; Lot Numbers: 038110 to 054926
Distribution pattern: US Nationwide.
Derived failure modes
-
Unknown
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.