Blueprint Mixed Reality Guidance Instrumentation System
Brand(s)
Last updated
Summary
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
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| Blueprint Mixed Reality BP MXR Depth Stop Pin | More than 10 numbers, contact manufacturer. | MRUE206 |
| Blueprint Mixed Reality BP MXR Coracoid Clamp | 23A362 22A976 22A544 23A008 23A364 23A365 23A363 22A543 22A975 | MRUE202 |
| Blueprint Mixed Reality Box Base | 22B823 22B883 22B821 22B882 22B822 22B884 22B820 | MRUE204 |
| Blueprint Mixed Reality BP MXR Glenoid Digitizer | More than 10 numbers, contact manufacturer. | MRUE201 |
| Blueprint Mixed Reality Glenoid Box Lid | 22B824 22B827 22B825 22B886 22B826 22B885 22B887 | MRUE205 |
| Blueprint Mixed Reality BP MXR Glenoid Pin Guide | 22C915 23A357 23B113 23B115 23B117 23A356 23B114 23B116 23B118 23A358 | MRUE200 |
| Blueprint Mixed Reality BP MXR Instrument Check Block | 23A812 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
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
Tornier S.A.S.
161, Rue Lavoisier, Montbonnot-Saint-Martin, France, 38330
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77078
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