⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Mazor Robotics Ltd: Mazor X robotic guidance system REF: TPL0059

Medical DevicesSource: FDA (device) · Date: 2026-01-28

Read the official notice at FDA (device) →

Share on XFacebookRedditEmail

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Mazor Robotics Ltd
Product
Mazor X robotic guidance system REF: TPL0059
Reason / hazard
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2025-12-10
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
Product quantity
549 systems
Voluntary mandated
Voluntary: Firm initiated
City
Caesarea
Country
Israel
Event id
98199
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.