Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guid
Summary
The FDA issued a Class II for Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the x by Augmedics Ltd.. 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..
Details
Source
Device Recall
External ID
Z-1761-2025
Action Date
2025-05-21
Status
Ongoing
Category
device
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.
Lot/Code Info: UDI: 07290113780910; Lot Numbers: 038110 to 054926
Quantity Affected: 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.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-14
Company
Yokneam Illit Northern
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 152 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Augmedics Ltd. has 6 FDA actions in our database, including 1 recall and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Augmedics Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Augmedics Ltd. have FDA actions?
Augmedics Ltd. has 6 FDA actions in our database, including 1 recall and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1761-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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