FDA Medical devices recall ·
Augmedics Perc Pin Adaptor, Model recall
- Recall number
- Z-1761-2025
- Date
- (initiated April 14, 2025)
- Company / brand
- Augmedics Ltd.
2 Ha-Otsma St, Yokneam Illit Northern, Israel - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 85 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI: 07290113780910; Lot Numbers: 038110 to 054926
Distribution
US Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1761-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.