PlainRecalls
FDA Devices Moderate Class II Ongoing

Stryker Blueprint Software, Catalog #BPUE001.

Reported: May 29, 2024 Initiated: April 16, 2024 #Z-1883-2024

Product Description

Stryker Blueprint Software, Catalog #BPUE001.

Reason for Recall

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.

Details

Recalling Firm
Tornier S.A.S.
Distribution
US Nationwide distribution in the states of FL, KY, NJ, and WI.
Location
Montbonnot St Martin

Frequently Asked Questions

What product was recalled?
Stryker Blueprint Software, Catalog #BPUE001.. Recalled by Tornier S.A.S..
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 29, 2024. Severity: Moderate. Recall number: Z-1883-2024.