Augmedics Ltd.: Device Recall
Recall #Z-1761-2025 · 04/14/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1761-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Augmedics Ltd.
- Status
- Ongoing
- Date Initiated
- 04/14/2025
- Location
- Yokneam Illit Northern, Israel
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85 units
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.
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.
Distribution Pattern
US Nationwide.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.