Reported Apr 20, 2016 · Terminated
X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized…
X-NAV Technologies, LLC
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: X-NAV Technologies, LLC · 1555 Bustard Rd Ste 75 · Lansdale, PA · 19446-5731
Is this the product you have?
- X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.
- Lot codes and dates
- Model Numbers
P007665 X-ClipComponent of System P007839
- NoteP007665 X-Clip Component is distributed as X-Clip Bulk Kit PN P008381, package of 12 pieces P007665
- Model Numbers
- Amount recalled
- 845 units (P007665)
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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