Robotic guidance systems recalled over incorrect surgical instrument positioning errors
Mazor Robotics is recalling 549 Mazor X robotic guidance systems over software errors that can result in incorrect surgical instrument positioning during spinal surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states software errors can result in incorrect surgical instrument positioning during spinal surgery, and no injuries are reported.
Plain-English summary
The Mazor X robotic guidance system, REF TPL0059, is being recalled by Mazor Robotics Ltd.
The reason given in the enforcement record is software errors that can result in incorrect surgical instrument positioning during spinal surgery.
The record lists 549 systems covering software versions 5.0.1, 5.1.2 and 5.1.3, with UDI codes recorded in the enforcement record. Distribution was worldwide, covering the United States nationwide and a wide range of other countries listed in the record. The FDA has classified the action as Class II.
Incorrect instrument positioning during spinal surgery is a risk to the patient. The enforcement record reports no injuries. Facilities should follow Mazor Robotics' instructions.
The recalled product
- Product
- Mazor X robotic guidance system REF: TPL0059
- Manufacturer
- Mazor Robotics Ltd
- Hazard
- software-fault
- instrument-positioning
- spinal-surgery
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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
Distributed nationwide across the United States.
Related recalls
Same category
- ModerateTosoh ST AIA-Pack Testosterone Diagnostic Test Kit Recall
FDA (Devices) · 2026-07-22
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
- ModeratePapablic Replacement Brush Heads Recalled Due to Breakage Risk
FDA (Devices) · 2026-07-22
- SevereICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery
FDA (Devices) · 2026-07-22
- SevereAbiomed Introducer Kit for Impella Heart Pump Sheath Leak Risk
FDA (Devices) · 2026-07-22