CLASS II ONGOING Device recall · Reported 29 May 2024 · FDA Enforcement Report

Stryker Blueprint recalled by Tornier S.A.S

Tornier S.A.S is recalling Stryker Blueprint, distributed nationwide in the US. The recall was initiated on 16 Apr 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.

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-1883-2024
FDA event ID: 94444
Recalling firm: Tornier S.A.S, Montbonnot St Martin
Classification: Class II
Status: Ongoing
Recall initiated: 16 Apr 2024
FDA classified: 22 May 2024
Reported: 29 May 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Medical Software

Timeline

16 Apr 2024	Recall initiated by company
22 May 2024	Classified by FDA	+36 days
29 May 2024	Published in enforcement report	+7 days

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

Reason for recall

The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.

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 Software, Catalog #BPUE001.

Where it was distributed

US Nationwide distribution in the states of FL, KY, NJ, and WI.

Nationwide Florida Kentucky New Jersey Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

Versions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.

Where was it sold?

US Nationwide distribution in the states of FL, KY, NJ, and WI.

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
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 BP MxR Glenoid Pin Guide recalled	Tornier S.A.S	Device Malfunction	7 states

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9 Sep 2026Device	CLASS II	Philips Brilliance CT 64: Brilliance CT 64 Channel recalled	Philips North America	Device Malfunction	MA
8 Sep 2026Device	ANNOUNCED	BMC Luna G3 APAP recalled by BMC MedicalBMC	BMC Medical	Device Malfunction	Nationwide