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U.S. Department of Health and Human Services

Class 2 Device Recall Augmedics

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 Class 2 Device Recall Augmedicssee related information
Date Initiated by FirmApril 14, 2025
Date PostedMay 13, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1761-2025
Recall Event ID 96686
510(K)NumberK211188 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductAugmedics 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.
Code Information UDI: 07290113780910; Lot Numbers: 038110 to 054926
FEI Number 3016571711
Recalling Firm/
Manufacturer		 Augmedics Ltd.
2 Ha-Otsma St
Yokneam Illit Northern Israel
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionA Customer Notification Letter was sent to customers beginning 4/14/25. Actions to be taken by the Customer/User. Augmedics has upgraded the Perc pin adaptor (AMCH07200) to a new design (AMCH07300). Based on user feedback, Augmedics decided to initiate a recall of the legacy units by removing the legacy units from the site and replace them with the upgraded design. Please acknowledge receipt of this notification by signing the Customer Notification Acknowledgement attached to this notification or by sending an email to Augmedics stating you have received the notification. Type of Action by the Company: "The customer is notified to stop using Perc pin adaptor AMCH07200 at the site, identified by their UDI: 07290113780910. "Augmedics representative shall remove all the affected parts (AMCH07200) from the site. "Augmedics representative shall notify the customer and provide this document to the site representative. "Augmedics representative shall provide the customer with replacement Perc pin adaptors of an updated design (AMCH07300). "Augmedics shall collect the signed Customer Notification Acknowledgement as evidence for customer notification. Contact Information: Address: Augmedics Inc. 21 S. Evergreen Ave Suite 230 Arlington Heights, IL 60005 Email: Customerservice@augmedics.com
Quantity in Commerce85 units
DistributionUS Nationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OLO
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