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Mazor™ x system

Official notice

19 Dec 2025

Last checked

19 Dec 2025

Medium riskHealth Canada

An official Health Canada notice concerns Mazor™ x system. Mazor software version 5.2 is an update to any prior software version, including software versions 5.0.1, 5.1.2, and 5.1.3. Of the 111 resolved anomalies within software version 5.2, 104 are evaluated as representing no or negligible harm. 7 are evaluated with observed or potential harm greater than negligible. Published 2025-12-19.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81382

Official notice

2025-12-19

The hazard

Mazor software version 5.2 is an update to any prior software version, including software versions 5.0.1, 5.1.2, and 5.1.3. Of the 111 resolved anomalies within software version 5.2, 104 are evaluated as representing no or negligible harm. 7 are evaluated with observed or potential harm greater than negligible.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Lots

4004121121, 4006550623, 4005601222, 4006110323, 4003770621, 4007070124

Skus

TPL0059

Other

RA RA-81382

Model Numbers

TPL0059

Recall Numbers

81382

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Affected products

Product 1

Affected products - Mazor™ X System, Lot or serial number - 4004121121, Model or catalogue number - TPL0059

Product 2

Affected products - Mazor™ X System, Lot or serial number - 4006550623, Model or catalogue number - TPL0059

Product 3

Affected products - Mazor™ X System, Lot or serial number - 4005601222, Model or catalogue number - TPL0059

Product 4

Affected products - Mazor™ X System, Lot or serial number - 4006110323, Model or catalogue number - TPL0059

Product 5

Affected products - Mazor™ X System, Lot or serial number - 4003770621, Model or catalogue number - TPL0059

Product 6

Affected products - Mazor™ X System, Lot or serial number - 4007070124, Model or catalogue number - TPL0059

Product 7

Lot or serial number - 4004121121, Model or catalogue number - TPL0059

Product 8

Lot or serial number - 4006550623, Model or catalogue number - TPL0059

Product 9

Lot or serial number - 4005601222, Model or catalogue number - TPL0059

Product 10

Lot or serial number - 4006110323, Model or catalogue number - TPL0059

Product 11

Lot or serial number - 4003770621, Model or catalogue number - TPL0059

Product 12

Lot or serial number - 4007070124, Model or catalogue number - TPL0059

Risk / hazard

Mazor software version 5.2 is an update to any prior software version, including software versions 5.0.1, 5.1.2, and 5.1.3. Of the 111 resolved anomalies within software version 5.2, 104 are evaluated as representing no or negligible harm. 7 are evaluated with observed or potential harm greater than negligible.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Mazor Robotics.

Source & status

Source

Health Canada

Tier

beta

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

81382

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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