Blueprint BPUE001 (REF 4.0.Win)Recalls & reported problems

Tornier · Win · Class 2

All models of Blueprint (4)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Apr 16, 2024Class IIOpen, Classified
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.
Z-1883-2024 · Root cause: Software change control · Recall details · FDA record ↗

Device details

UDI-DI	`03700434015058`
Brand	Blueprint
Model	BPUE001
Catalog no.	4.0.Win
Company	Tornier
Product code	QHE · Shoulder arthroplasty implantation system
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 7, 2024

Device type (GMDN): Orthopaedic CAD/CAM system

An assembly of software-based devices designed for automated computer-aided design (CAD) and computer-aided manufacturing (CAM) of custom-made (specifically prescribed to each patient's needs) orthopaedic implants typically involving the prescription forming (milling) of the femoral stem of a hip replacement for optimal fitting to that patient's bone anatomy. It typically includes three-dimensional (3-D) image acquisition and viewing capabilities that provide values (measurements) for the production phase, software for record collection, treatment planning, simulation and device production, and robotic capabilities for production of the prosthesis to be fitted to the patient.

Other Shoulder arthroplasty implantation system devices

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Orthosoft Inc · Shoulder Arthroplasty Implantation System
1 report
Arthrex® 5566VIP
Arthrex, Inc. · Shoulder arthroplasty implantation system
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Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left 20-8090-004-01
Orthosoft Inc · Shoulder Arthroplasty Implantation System
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All Shoulder arthroplasty implantation system devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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