Tornier S.A.S.: Stryker Blueprint Software, Catalog #BPUE001.

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.

Details from the source

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. Distribution: US Nationwide distribution in the states of FL, KY, NJ, and WI. Lot/code info: Versions 2.1.4 to 4.0.2, UDI-DI numbers 03700434023114, 03700434023107, 03700434015065, and 03700434015058.

UPC codes

03700434023114, 03700434023107, 03700434015065, 03700434015058

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.