Class IIReported 2026-01-28

Mazor X robotic guidance system REF: TPL0059

Recalled by Mazor Robotics Ltd

Reason for Recall

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

Recall Number

Z-1122-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-10

Reported

2026-01-28

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.

Code Info

Software versions: 5.0.1, 5.1.2, 5.1.3/ UDI: 07290109180465, 07290109184524, 07290109181158, 00763000635169, 07290109183213, 07290109184517, 00763000419134, 00763000431761, 07290109184098, 07290109184838, 07290115751376, 07290115751895

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.