Reported May 21, 2025 · Ongoing
Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an…
Augmedics Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Augmedics Ltd. · 2 Ha-Otsma St · Yokneam Illit Northern · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- UDI07290113780910
- Lot Numbers038110 to 054926
- Amount recalled
- 85 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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