fda
10 records
FDA Recall: Tornier S.A.S. — Class II
20250416
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactor | Product: stryker Blueprint Mixed Reality Coraco...
View Source
FDA Recall: Tornier S.A.S. — Class II
20250416
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactor | Product: stryker Blueprint Mixed Reality Glenoi...
View Source
FDA Device Recall: Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical pla
2025-05-14
Class II — A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
View Source
FDA Device Recall: stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged
2025-04-16
Class II — Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the...
View Source
FDA Device Recall: stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packa
2025-04-16
Class II — Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the...
View Source
FDA Device Recall: stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Sh
2025-04-16
Class II — Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the...
View Source
FDA Device Recall: stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Sh
2025-04-16
Class II — Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the...
View Source
FDA Device Recall: stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in st
2025-04-16
Class II — Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the...
View Source
FDA Device Recall: Stryker Blueprint Software, Catalog #BPUE001.
2024-05-29
Class II — 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 no...
View Source
FDA Device Recall: The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS on
2021-08-25
Class II — Potential patient exposure to the graphite substrate.
View Source
Be informed when major changes happen on C.F.A.I. — new data sources, platform updates, critical enforcement alerts
No spam. Only major updates. Unsubscribe anytime.