FDA recall Z-1122-2026

Product

Mazor X robotic guidance system REF: TPL0059

Reason for recall

Software errors that can result in incorrect surgical instrument positioning during spinal surgery.

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, China, Croatia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Vietnam.

Key facts

Status

Ongoing

Initiation date

2025-12-10

Report date

2026-01-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Caesarea, Israel

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1122-2026