| 2021-12-29 |
Class II
|
Terminated |
Z-0533-2022 |
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. |
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The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the inser… |
| 2020-09-30 |
Class III
|
Terminated |
Z-0429-2021 |
XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Re… |
— |
Cervical Implants contain a label that incorrectly identifies the grade of titanium used. |
| 2020-05-12 |
Class II
|
Terminated |
Z-2500-2020 |
Irix-C Forceps Inserter; Product Code/UDI: T066-0059/ M697T06600591 |
— |
The strike plate fractured off from the forceps inserter devices with minimal impaction or force due to unsatisfactory weld. |