FDA recall Z-0533-2022

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-12-29

Report date

2022-02-09

Termination date

2024-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Belgrade, MT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0533-2022