X-Guide Surgical Navigation System recall
X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide…
Why was X-Guide Surgical Navigation System recalled?
The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials to assist with registration of the patient anatomy. The X-Clip is a device worn intraorally by a patient during the CT scan and guided surgery procedures. The X-Clip contains three fiducial markers made from a Stainless Steel material. The X-Nav specification requires these fiducials be fabricated from Stainless Steel 3
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Numbers: P007665 X-Clip; Component of System P007839. Note: P007665 X-Clip Component is distributed as X-Clip Bulk Kit PN P008381, package of 12 pieces P007665.
- Product
- X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide…
- Recalling firm
- X-NAV Technologies, LLC
- Quantity
- 845 units (P007665)
- Distribution
- US Distribution to: FL, OR, NE, PA, NM, FL, VA, OH, WA, CA, MD, LA, ID, CN, TN, and DC.
- Recall date
- April 20, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)