Agency classClass IIOur severity:High FDA (Devices)·Z-1122-2026·Announced 2026-01-28

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Category: Medical Device — Surgical robotics
Hazard: software-fault
instrument-positioning
spinal-surgery
Affected units: 549

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.

Same manufacturer · Mazor Robotics Ltd

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Same hazard · software fault