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Mazor X System
Model TPL0059-06 · MAZOR ROBOTICS LTD · DI 07290109183213
HAW — Neurological Stereotaxic Instrument · Class II · 21 CFR 882.4560
LLZ — System, Image Processing, Radiological · Class II · 21 CFR 892.2050
OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560
UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (2)
Initiated
Recall #
Class
Status
Reason
Link basis
2025-12-10
Z-1122-2026
Class II
Open, Classified
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
code info di
2023-09-05
Z-0101-2024
Class II
Open, Classified
Software update
code info di
Adverse-event reports — MAUDE (394)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Malfunction: 337 · Injury: 55 · Death: 2
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
8.9
2019-02
0
9.8
2019-03
0
9.75
2019-04
0
11.69
2019-05
0
13.12
2019-06
2
12.96
2019-07
0
9.95
2019-08
0
7.99
2019-09
0
7.92
2019-10
0
7.3
2019-11
0
9.9
2019-12
0
10.2
2020-01
2
7.88
2020-02
2
9.2
2020-03
2
9.63
2020-04
3
9.82
2020-05
2
11.02
2020-06
4
8.31
2020-07
4
9.32
2020-08
0
8.15
2020-09
3
8.27
2020-10
5
9.59
2020-11
4
10.39
2020-12
3
8.93
2021-01
6
8.68
2021-02
3
9.35
2021-03
2
8.99
2021-04
7
8.52
2021-05
12
9.47
2021-06
6
10.69
2021-07
4
8.42
2021-08
6
9.77
2021-09
2
12.18
2021-10
6
7.93
2021-11
12
10.31
2021-12
4
7.26
2022-01
4
6.61
2022-02
4
7.31
2022-03
0
8.86
2022-04
3
6.09
2022-05
1
8.41
2022-06
3
8.93
2022-07
2
8.26
2022-08
3
8.34
2022-09
2
8.3
2022-10
6
10.94
2022-11
3
9.53
2022-12
3
9.44
2023-01
4
8.45
2023-02
2
7.9
2023-03
4
9.28
2023-04
4
9.15
2023-05
1
9.77
2023-06
0
11.43
2023-07
3
12.71
2023-08
0
12.41
2023-09
1
10.13
2023-10
3
10.28
2023-11
2
13.1
2023-12
7
10.93
2024-01
4
15.12
2024-02
6
11.44
2024-03
7
13.24
2024-04
6
12.3
2024-05
4
11.41
2024-06
3
10.73
2024-07
9
12.56
2024-08
3
17.28
2024-09
2
13.51
2024-10
3
16.9
2024-11
6
10.13
2024-12
2
9.94
2025-01
46
11.72
2025-02
39
13.25
2025-03
3
11.17
2025-04
1
12.54
2025-05
4
11.8
2025-06
7
14.78
2025-07
2
11.03
2025-08
5
9.86
2025-09
0
9.79
2025-10
3
10.5
2025-11
6
8.59
2025-12
22
8.49
2026-01
20
9.73
2026-02
6
7.66
2026-03
2
10.03
2026-04
1
8.18
2026-05
1
9.32
2026-06
0
6.38
This device (reports/month)Average device in HAW, LLZ, OLO (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — MAZOR ROBOTICS LTD