FDA (Devices) recall action 96437

Tornier S.A.S. recalled 9 products on 2025-04-16

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2025-04-16
Critical: 0
Units: 652

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–9 of 9

ModerateFDA (Devices)··2025-04-16
Stryker Blueprint Mixed Reality surgical guidance system Class II recall
Stryker is recalling the Blueprint Mixed Reality Box Base used in Total Shoulder Arthroplasty due to elevated complaints of software and instrumentation malfunctions that prevent intended use.
Product
stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Category
Distribution
7 states
HighFDA (Devices)··2025-04-16
Stryker Blueprint Mixed Reality Instrument Check Block Recall
Tornier S.A.S. is recalling the Stryker Blueprint Mixed Reality Instrument Check Block (Catalog Number MRUE203) due to an elevated complaint rate involving software and instrumentation malfunctions that prevent the system from functioning as intended.
Product
stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Category
Distribution
7 states
ModerateFDA (Devices)··2025-04-16
Stryker Blueprint Mixed Reality Coracoid Clamp Software and Instrumentation Issues
Stryker is recalling the Blueprint Mixed Reality Coracoid Clamp due to elevated complaints about impaired software and instrumentation functioning that prevent the system from meeting its intended use in shoulder surgery guidance.
Product
stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Category
Distribution
7 states
ModerateFDA (Devices)··2025-04-16
Stryker Blueprint Mixed Reality Glenoid Pin Guide Impaired Function Recall
Tornier S.A.S. is recalling the Stryker Blueprint Mixed Reality Glenoid Pin Guide due to elevated complaint rates regarding software and instrumentation functioning issues that prevent the product from meeting its intended use.
Product
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
Category
Distribution
7 states
ModerateFDA (Devices)··2025-04-16
Stryker Blueprint Mixed Reality Instrument Kit Recall for Total Shoulder Arthroplasty
Stryker is recalling the Blueprint Mixed Reality Instrument Kit for Total Shoulder Arthroplasty due to an elevated rate of complaints about software and instrumentation malfunctions that prevent the system from meeting its intended use.
Product
stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Category
Distribution
7 states
ModerateFDA (Devices)··2025-04-16
Stryker Blueprint Mixed Reality Glenoid Box Lid system functionality issues
Stryker is recalling the Blueprint Mixed Reality Glenoid Box Lid and related instrumentation kits due to elevated complaint rates. The product experiences software and instrumentation issues that prevent it from meeting its intended use.
Product
stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Category
Distribution
7 states
ModerateFDA (Devices)··2025-04-16
Stryker HoloBlueprint Application Medical Device Software Functionality Recall
Stryker is recalling the HoloBlueprint Application (Catalog Number MRUE001) for Total Shoulder Arthroplasty due to software and instrumentation malfunctions that prevent the system from meeting its intended use.
Product
stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
Category
Distribution
7 states
ModerateFDA (Devices)··2025-04-16
Stryker Blueprint Mixed Reality Depth Stop Pin Total Shoulder Arthroplasty Recalled
Stryker is recalling the Blueprint Mixed Reality Depth Stop Pin (Catalog Number MRUE206) due to elevated complaints of software and instrumentation malfunctions that prevent intended use. The recall affects 474 units distributed in multiple US states and internationally.
Product
stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
Category
Distribution
7 states
ModerateFDA (Devices)··2025-04-16
Stryker Blueprint Mixed Reality Glenoid Digitizer Software Functioning Issues
Stryker is recalling the Blueprint Mixed Reality Glenoid Digitizer due to elevated complaint rates affecting system functionality. The device cannot reliably meet its intended use in total shoulder arthroplasty procedures.
Product
stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Category
Distribution
7 states