Mazor X Surgical Navigation Device Recalled for Software Display and Screw Tracking Errors
Mazor Robotics is recalling 94 Mazor X surgical navigation devices due to software errors that cause screen lag or screw-tracking mismatches during orthopedic procedures.
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: This is an FDA Class II device recall involving software errors in a surgical navigation system. Although no injuries or hospitalizations have been reported, the product qualifies as risk-of-harm because incorrect screw placement during orthopedic surgery could result in serious patient harm.
Plain-English summary
Mazor Robotics Ltd is recalling the Mazor X surgical navigation system (Model Number REF TPL0059), a stereotaxic orthopedic instrument. The recall affects 94 devices with multiple lot numbers distributed nationwide.
The recall is due to software anomalies that can cause two issues: a lagging screen display during navigated surgical procedures, or a mismatch between the screw position the system navigated to and the screw information displayed on screen. These errors could affect the accuracy of screw placement during orthopedic surgery.
Hospitals and surgical centers using the Mazor X system should identify affected devices by their lot numbers and contact Mazor Robotics. Surgeons should verify that actual screw placement matches the navigated position before completing procedures. The FDA has classified this as a Class II device recall.
The recalled product
- Product
- Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument
- Manufacturer
- Mazor Robotics Ltd
- Affected units
- 94
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 (20)
- UDI/DI 07290109180465
- Lot Numbers: 400-38-122016
- 400-44-022017
- 400-67-062017
- 400-69-062017
- UDI/DI 07290109181158
- Lot Numbers: 4001200218
- 4001970419
- 4001011117
- 4001041117
- 4001061117
- 4001320518
- 4001330618
- 4001390818
- 4001430918
- 4001631218
- 4001690119
- 4001710119
- 4001780219
- 4001790219
Distribution
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