CLASS II ONGOING Device recall · Reported 16 Apr 2025 · FDA Enforcement Report

stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide recalled

Tornier S.A.S is recalling stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, distributed in 7 states. The recall was initiated on 5 Mar 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022926

Quantity recalled3 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1534-2025
FDA event ID: 96437
Recalling firm: Tornier S.A.S, Montbonnot-Saint-Martin, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 5 Mar 2025
FDA classified: 8 Apr 2025
Reported: 16 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Hip & Knee Implants

Timeline

5 Mar 2025	Recall initiated by company
8 Apr 2025	Classified by FDA	+34 days
16 Apr 2025	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

Where it was distributed

US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland

Alaska Idaho Massachusetts Minnesota Pennsylvania Tennessee Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022926

Where was it sold?

US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

8 other products · FDA event 96437

This product is part of a recall event; the main page for the event is stryker Blueprint Mixed Reality Coracoid Clamp recalled by Tornier S.A.S.

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025	CLASS II	stryker Blueprint Mixed Reality Coracoid Clamp recalled by Tornier S.A.S	Tornier S.A.S	Device Malfunction	7 states
16 Apr 2025	CLASS II	stryker Blueprint Mixed Reality Glenoid Digitizer recalled	Tornier S.A.S	Device Malfunction	7 states
16 Apr 2025	CLASS II	stryker Blueprint Mixed Reality Depth Stop Pin recalled by Tornier S.A.S	Tornier S.A.S	Device Malfunction	7 states
16 Apr 2025	CLASS II	stryker Blueprint Mixed Reality Instrument Kit recalled by Tornier S.A.S	Tornier S.A.S	Device Malfunction	7 states
16 Apr 2025	CLASS II	stryker Blueprint Mixed Reality Box Base recalled by Tornier S.A.S	Tornier S.A.S	Device Malfunction	7 states
16 Apr 2025	CLASS II	stryker Blueprint Mixed Reality Instrument Check Block recalled	Tornier S.A.S	Device Malfunction	7 states
16 Apr 2025	CLASS II	stryker HoloBlueprint Application recalled by Tornier S.A.S	Tornier S.A.S	Device Malfunction	7 states
16 Apr 2025	CLASS II	stryker Blueprint Mixed Reality Glenoid Box Lid recalled	Tornier S.A.S	Device Malfunction	7 states

More recalls from Tornier S.A.S

All 13

Reported	Class	Recall	Company	Reason	Where
14 May 2025Device	CLASS II	Blueprint Software, BPUE001. Intended for use by surgeons as a pre recalled	Tornier S.A.S	Device Malfunction	Nationwide
16 Apr 2025Device	CLASS II	stryker Blueprint Mixed Reality Glenoid Box Lid recalled	Tornier S.A.S	Device Malfunction	7 states
16 Apr 2025Device	CLASS II	stryker HoloBlueprint Application recalled by Tornier S.A.S	Tornier S.A.S	Device Malfunction	7 states
16 Apr 2025Device	CLASS II	stryker Blueprint Mixed Reality Instrument Check Block recalled	Tornier S.A.S	Device Malfunction	7 states
16 Apr 2025Device	CLASS II	stryker Blueprint Mixed Reality Box Base recalled by Tornier S.A.S	Tornier S.A.S	Device Malfunction	7 states

Other Hip & Knee Implants recalls

All 3,111

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Intellijoint Navigation System: Workstation G2 Configured recalled	Intellijoint Surgical	Device Malfunction	Nationwide
30 Sep 2026Device	CLASS II	Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled	New York Embroidery Studio	Packaging Defects	Nationwide
23 Sep 2026Device	CLASS II	Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled	Howmedica Osteonics	Other	Nationwide
23 Sep 2026Device	CLASS II	Scorpio Recessed Metal Backed Patella 3045 recalled	Howmedica Osteonics	Foreign Material	Nationwide