XTANT Medical: Medical Device Recall in 2022 - (Recall #: Z-0533-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.

Product Classification:

Class II

Date Initiated: December 29, 2021

Date Posted: February 9, 2022

Recall Number: Z-0533-2022

Event ID: 89367

Reason for Recall:

The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.

Status: Terminated

Product Quantity: 24 devices

Code Information:

X060-0270, 8mm Titanium Insert, Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963

Distribution Pattern:

U.S.: CA, MI, NV, and TX O.U.S.: Portugal

Voluntary or Mandated:

Voluntary: Firm initiated