FDA DevicesClass II
Mazor X robotic guidance system REF: TPL0059
Published: January 28, 2026Recall ID: Z-1122-2026Category: devicesCountry: US
Reason for Recall / Hazard
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Product Description & Identification
Mazor X robotic guidance system REF: TPL0059
Affected Products
Mazor X robotic guidance system REF: TPL0059
Additional Source Details
| Field | Value |
|---|---|
| City | Caesarea |
| Event id | 98199 |
| Address 1 | North Industrial Park |
| Address 2 | 5, Shakham |
| 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 |
| Postal code | N/A |
| Report date | 20260128 |
| Product type | Devices |
| Product quantity | 549 systems |
| Reason for recall | Software errors that can result in incorrect surgical instrument positioning during spinal surgery. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251210 |
| Initial firm notification | Letter |
| Center classification date | 20260116 |
Overview
- Recalling FirmMazor Robotics Ltd
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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.