Recall Monitor
Health Products

Mazor™ X System

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Orthopaedics
Product: Mazor™ X System
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Mazor™ X System4004121121TPL0059
Mazor™ X System4006550623TPL0059
Mazor™ X System4005601222TPL0059
Mazor™ X System4006110323TPL0059
Mazor™ X System4003770621TPL0059
Mazor™ X System4007070124TPL0059

Issue

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.

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