Recall Z-1391-2016 ยท PLV Dental Stereotaxic Instrument
X-NAV Technologies, LLC
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.
| Date | Feb 23, 2016 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Nonconforming Material/Component |
| Action | The firm, X-Nav Technologies, LLC, sent a "Medical Device Recall" letter date 2/23/2016 via mail and email to customers indicating the issue and risks involved. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory of X-Clips and remove any product containing the affected lots; complete the enclosed Acknowledgement and Receipt form to record the lot numbers located on the labeling for parts and discard affected product and return form to firm by Email to: Vigilance@X-Navtech.com or by Mail to: X-NAV TECHNOLOGIES, |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150222 | X-Guide Surgical Navigation System X-Nav Technologies, LLC, Oct 8, 2015 |