Tornier S.A.S. recall records

12 reported ongoing

12 records in this archive. Latest source date Apr 10, 2025.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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

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

Class IIReported ongoing

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

Official source for Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder ...
FDA device enforcement

stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Numb...

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 co...

Class IIReported ongoing

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

Official source for stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number M...
FDA device enforcement

stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Art...

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 co...

Class IIReported ongoing

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

Official source for stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Bl...
FDA device enforcement

stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthro...

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 co...

Class IIReported ongoing

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

Official source for stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Bluep...
FDA device enforcement

stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulde...

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 co...

Class IIReported ongoing

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

Official source for stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryk...
FDA device enforcement

stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

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 co...

Class IIReported ongoing

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

Official source for stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint M...
FDA device enforcement

stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthr...

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 co...

Class IIReported ongoing

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

Official source for stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blue...
FDA device enforcement

stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty

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 co...

Class IIReported ongoing

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

Official source for stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
FDA device enforcement

stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

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 co...

Class IIReported ongoing

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

Official source for stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
FDA device enforcement

stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty

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 co...

Class IIReported ongoing

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

Official source for stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
FDA device enforcement

Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.

The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical metho...

Class IIReported ongoing

Distribution: US: MN, KY, MD, MA, TX, AK, TX, ID; France, Canada

Official source for Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during T...

Reasons in these listed records

  • A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
  • 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 relate...
  • The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to con...
  • 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.

These examples come from this result page and are not a ranking of every recall reason.

Checking Tornier S.A.S.

Is there a recall on tornier s.a.s. right now?

This archive contains 12 records, including 12 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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