FDA recall Z-3156-2024

Product

Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument

Reason for recall

Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen.

Distribution

US Nationwide distribution in PR.

Key facts

Status

Ongoing

Initiation date

2024-07-17

Report date

2024-09-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Caesarea, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3156-2024