FDAFDA · Food and drugs·Recall number Z-1883-2024
Stryker Blueprint Software, Catalog #BPUE001.
Published May 29, 2024 · Recall initiated: April 16, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Tornier S.A.S.
- Distributor
- US Nationwide distribution in the states of FL, KY, NJ, and WI.
- Lot
- Versions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- France
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