Tornier S.a.s.
161 rue Lavoisier, Montbonnot Saint-Martin Isere, FR
Registered product codes
45 product codes
Recent MDR events
4,146 on file
- Unknown perform fracture implantsJul 31, 2026Injury3000931034-2026-00593
- AEQ REV II GLENOID SPHERE DIA 39 X 25 CENTERED BASEPLATEJul 28, 2026Injury3000931034-2026-00588
- TORNIER FLEX SHOULDER SYS REV TRAY 0TH 3.5MM OFFSETJul 28, 2026Injury3000931034-2026-00589
- TORNIER FLEX SHOULDER SYS REVINSERT 39MM 6TH C 7.5DGJul 28, 2026Injury3000931034-2026-00590
- AEQ REV II GLENOID BASEPLATE DIA 25MM LONG POSTJul 28, 2026Injury3000931034-2026-00591
- D.4,5MM COMPRESSION SCREW L.20MMJul 28, 2026Injury3000931034-2026-00592
- TORNIER FLEX SHOULDER SYS STD HUM PTC STEM 3A 127.5DG 74MMJul 27, 2026Injury3000931034-2026-00585
- AEQUALIS REVERSED MULTIDIR SCREW D4.5 L 26 STERILEJul 27, 2026Injury3000931034-2026-00586
- AEQUALIS REVERSED MULTIDIR SCREW D4.5 L 26 STERILEJul 27, 2026Injury3000931034-2026-00587
- UNKNOWN FLEX IMPLANTSJul 21, 2026Injury3000931034-2026-00581
Recalls
13 on file
- Open, ClassifiedMay 8, 2025
A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
View FDA record ↗ - Open, ClassifiedApr 8, 2025
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 system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
View FDA record ↗ - Open, ClassifiedApr 8, 2025
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 system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
View FDA record ↗ - Open, ClassifiedApr 8, 2025
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 system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
View FDA record ↗ - Open, ClassifiedApr 8, 2025
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 system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
View FDA record ↗ - Open, ClassifiedApr 8, 2025
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 system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
View FDA record ↗ - Open, ClassifiedApr 8, 2025
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 system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
View FDA record ↗ - Open, ClassifiedApr 8, 2025
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 system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
View FDA record ↗ - Open, ClassifiedApr 8, 2025
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 system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
View FDA record ↗ - Open, ClassifiedApr 8, 2025
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 system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
View FDA record ↗
Compliance history
Matched by FEI 3000931034.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.