Blueprint BPUE001 (REF 4.0.Mac)Recalls & reported problems
Tornier · Mac · Class 2
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Apr 16, 2024Open, 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 · FDA record ↗
Other Shoulder arthroplasty implantation system devices
- CORE Shoulder System 87-9136Link Bio Corp · Shoulder Arthroplasty Implantation System1 recall1 report
- Blueprint BPUE001Tornier · Shoulder arthroplasty implantation system1 recall0 reports
- Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left 20-8090-004-01Orthosoft Inc · Shoulder Arthroplasty Implantation System1 report
- Arthrex® 5566VIPArthrex, Inc. · Shoulder arthroplasty implantation system1 report
- Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Right 20-8090-004-02Orthosoft Inc · Shoulder Arthroplasty Implantation System1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.