Montbonnot-Saint-Martin, N/A, France
Tornier S.A.S. recalls
5 recalls recorded since 2018, most recently on 10 April 2025. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)5
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 10 April 2025
- Reason
- A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
- Distribution
- Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1738-2025
- Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Ongoing Class II Medical devices
- Recall started
- 5 March 2025
- Reason
- 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.
- Distribution
- US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1536-2025, Z-1535-2025, Z-1540-2025, Z-1541-2025, Z-1538-2025, Z-1534-2025, Z-1537-2025, Z-1542-2025, Z-1539-2025
- stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
- stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- stryker Blueprint Mixed Reality Box Base, Catalog Number MRUE204, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU + Stainless Steel, Catalog Number MRUE200, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
- and 1 more product lines
Ongoing Class II Medical devices
- Recall started
- 18 December 2024
- Reason
- The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.
- Distribution
- US: MN, KY, MD, MA, TX, AK, TX, ID; France, Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0846-2025
- Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
Ongoing Class II Medical devices
- Recall started
- 16 April 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1883-2024
- Stryker Blueprint Software, Catalog #BPUE001.
Ongoing Class II Medical devices
- Recall started
- 25 June 2021
- Reason
- Potential patient exposure to the graphite substrate.
- Distribution
- CA, CO, CT, FL, KS, LA, MD, MI, MN, MO, NC, OR, PA, TX and WI
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2291-2021
- The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Heigh
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.