Mazor Robotics Ltd: Medical Device Recall in 2026 - (Recall #: Z-1122-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

Mazor X robotic guidance system REF: TPL0059

Product Classification:

Class II

Date Initiated: December 10, 2025

Date Posted: January 28, 2026

Recall Number: Z-1122-2026

Event ID: 98199

Reason for Recall:

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

Status: Ongoing

Product Quantity: 549 systems

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated