Health Products

Blueprint Mixed Reality Guidance Instrumentation System

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Neurology
Product: Blueprint Mixed Reality Guidance Instrumentation System
Issue: Medical devices - Performance
What to do: No impacted product has been distributed to Canadian customers.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
Blueprint Mixed Reality BP MXR Depth Stop PinMore than 10 numbers, contact manufacturer.MRUE206
Blueprint Mixed Reality BP MXR Coracoid Clamp23A362
22A976
22A544
23A008
23A364
23A365
23A363
22A543
22A975
MRUE202
Blueprint Mixed Reality Box Base22B823
22B883
22B821
22B882
22B822
22B884
22B820
MRUE204
Blueprint Mixed Reality BP MXR Glenoid DigitizerMore than 10 numbers, contact manufacturer.MRUE201
Blueprint Mixed Reality Glenoid Box Lid22B824
22B827
22B825
22B886
22B826
22B885
22B887
MRUE205
Blueprint Mixed Reality BP MXR Glenoid Pin Guide22C915
23A357
23B113
23B115
23B117
23A356
23B114
23B116
23B118
23A358
MRUE200
Blueprint Mixed Reality BP MXR Instrument Check Block23A812
22C800
22A533
22A977
MRUE203

Issue

The nonconformance identified was that the overall complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation System was determined to have exceeded the anticipated complaint rate threshold. Recall Start Date: February 24, 2025

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