Z-1761-2025 Class II Ongoing
FDA device recall Z-1761-2025 was initiated by Augmedics Ltd. on April 14, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 85 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2025
- Initiation Date
- April 14, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 85 units
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.
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.
Distribution Pattern
US Nationwide.
Code Information
UDI: 07290113780910; Lot Numbers: 038110 to 054926