FDA Enforcement
Class II
Ongoing
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.
Recall: Z-1761-2025
·
Reported May 21, 2025
Enforcement
- Recall Number
- Z-1761-2025
- Event ID
- 96686
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Augmedics Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 21, 2025
- Initiation Date
- April 14, 2025
- Classification Date
- May 13, 2025
- Address
- 2 Ha-Otsma St, Yokneam Illit Northern, N/A, Israel
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.
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 Info
UDI: 07290113780910; Lot Numbers: 038110 to 054926
Distribution
US Nationwide.
Quantity
85 units