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Tornier S.A.S. FDA Recalls
13 recalls on file across devices, 0 of them Class I and 13 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.Class IIApr 10, 2025A software bug in Blueprint version 4.2.1 prevents users fro |
| stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality InstrumentClass IIMar 5, 2025Stryker identified an elevated complaint rate related to dif |
| stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality InstClass IIMar 5, 2025Stryker identified an elevated complaint rate related to dif |
| stryker Blueprint Mixed Reality Glenoid Box Lid, Catalog Number MRUE205, packaged in stryker Blueprint Mixed Reality InsClass IIMar 5, 2025Stryker identified an elevated complaint rate related to dif |
| stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in strClass IIMar 5, 2025Stryker identified an elevated complaint rate related to dif |
| stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed RealClass IIMar 5, 2025Stryker identified an elevated complaint rate related to dif |
| stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder ArthroplastyClass IIMar 5, 2025Stryker identified an elevated complaint rate related to dif |
| stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality IClass IIMar 5, 2025Stryker identified an elevated complaint rate related to dif |
| stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder ArthroplastyClass IIMar 5, 2025Stryker identified an elevated complaint rate related to dif |
| stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder ArthroplastyClass IIMar 5, 2025Stryker identified an elevated complaint rate related to dif |
| Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder ArthroClass IIDec 18, 2024The Pin Guide is being recalled because the metal tube may d |
| Stryker Blueprint Software, Catalog #BPUE001.Class IIApr 16, 2024The software bug allows for case planning with anatomic glen |
| The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 Class IIJun 25, 2021Potential patient exposure to the graphite substrate. |