Recall record at a glance
| Official record | Z-1391-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | X-NAV Technologies, LLC |
| Report date | Apr 20, 2016 |
| Recall initiation date | Feb 23, 2016 |
| Quantity | 845 units (P007665) |
| Location | Lansdale, PA, United States |
Official product description
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.
Why the product 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
Distribution information
US Distribution to: FL, OR, NE, PA, NM, FL, VA, OH, WA, CA, MD, LA, ID, CN, TN, and DC.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: N/A.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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