[pending] Mazor X robotic guidance system REF: TPL0059
Pending LLM rewrite. Source: FDA_DEVICE Z-1122-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
The recalled product
- Product
- Mazor X robotic guidance system REF: TPL0059
- Manufacturer
- Mazor Robotics Ltd
- Category
- Medical Device — Devices
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.
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