Drug & Device Safety Atlas

FDA recall record · openFDA

Tornier S.A.S.

12 FDA recalls on record (2024–2025) — 12 device. 12 still ongoing.

0
Class I (most serious)
12
Class II
0
Class III
12
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrum 9
The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humera 1
A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the soft 1
The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the B 1

Recalls

stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Inst Class II 2025-03-05 stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality I Class II 2025-03-05 stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty Class II 2025-03-05 stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty Class II 2025-03-05 stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Class II 2025-03-05 Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement. Class II 2025-04-10 stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in str Class II 2025-03-05 stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Real Class II 2025-03-05 stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty Class II 2025-03-05 stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality Ins Class II 2025-03-05 Stryker Blueprint Software, Catalog #BPUE001. Class II 2024-04-16 Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthro Class II 2024-12-18

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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