CLASS II ONGOING Device recall · Reported 14 May 2025 · FDA Enforcement Report

Blueprint Software, BPUE001. Intended for use by surgeons as a pre recalled

Tornier S.A.S is recalling Blueprint Software, BPUE001. Intended for use by surgeons as a pre, distributed nationwide in the US. The recall was initiated on 10 Apr 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Version 4.2.1

Quantity recalled438 users

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-1738-2025
FDA event ID: 96651
Recalling firm: Tornier S.A.S, Montbonnot-Saint-Martin, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 10 Apr 2025
FDA classified: 8 May 2025
Reported: 14 May 2025
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

10 Apr 2025	Recall initiated by company
8 May 2025	Classified by FDA	+28 days
14 May 2025	Published in enforcement report	+6 days

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

Reason for recall

A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.

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

Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.

Where it was distributed

Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide.

Nationwide

Questions about this recall

Why was it recalled?

A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.

Which lots are affected?

Software Version 4.2.1

Where was it sold?

Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide.

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.

More recalls from Tornier S.A.S

All 13

Reported	Class	Recall	Company	Reason	Where
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 BP MxR Glenoid Pin Guide 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 Surgical Instruments recalls

All 3,891

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	Adaptable Beach Chair Beach Chair surgical patient positioner recalled	Quantum OPS	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	Laparoscopic Prostatectomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Halyard Laparoscopy Comprehensive Pack II recalled	GRI Medical & Electronic Technology	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy/Laparotomy kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Gyn Laparoscopy Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide