X-NAV Recalls X-Guide Surgical Navigation System X-Clip Bulk Kits
X-NAV Technologies is recalling 845 X-Guide Surgical Navigation System X-Clip Bulk Kits because the stainless steel fiducials may not meet specifications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is a material specification deviation rather than a direct acute physical hazard like fire or choking.
Plain-English summary
X-NAV Technologies, LLC is recalling 845 units of the X-Guide Surgical Navigation System X-Clip Bulk Kit (PN P008381). The X-Clip is a component of the X-Guide system (P007839) intended to assist in preoperative planning and intra-operative surgical phases of dental implantation procedures. The device is worn intraorally by patients during CT scans and guided surgery to assist with the registration of patient anatomy.
The recall is due to a manufacturing defect where the three fiducial markers inside the X-Clip may not be fabricated from the required Stainless Steel 3 material. The X-Clip is distributed as a bulk kit containing 12 pieces of the P007665 X-Clip component.
The affected units were distributed in the United States to Florida, Oregon, Nebraska, Pennsylvania, New Mexico, Virginia, Ohio, Washington, California, Maryland, Louisiana, Idaho, Connecticut, Tennessee, and the District of Columbia. Consumers and healthcare providers should stop using the affected X-Clip components and contact X-NAV Technologies for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- X-NAV Technologies, LLC
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model Numbers: P007665 X-Clip
- package of 12 pieces P007665.
Distribution
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