XTANT Medical

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0533-2022Class IIX060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.December 29, 2021
Z-0429-2021Class IIIXTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, September 30, 2020
Z-2500-2020Class IIIrix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591May 12, 2020
Z-1526-2020Class IIOsteoSelect Demineralized Bone Matrix (DBM) Putty 10.0cc in a syringe; STERILE R, Product Code: 3591May 3, 2019
Z-0790-2019Class IICalix Lumbar Spinal Implant System: 22mm x 10mm x 7mm PLIF ASSY PC, REF X034-0172PC 22mm x 10mm x December 19, 2018
Z-1884-2017Class II5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastiApril 12, 2017