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Blueprint Mixed Reality recallZ-1535-2025 · Tornier S.A.S. · initiated Mar 5, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Tornier S.A.S. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 03/12/2025 via email. The notice explained the issue and requested the following: "1. Immediately check your internal inventory to locate the product listed on the attached business reply form, remove them from their point of use, and isolate/quarantine the unit(s) to prevent accidental use. 2. Return the enclosed business reply form by email to confirm receipt of this notification/document product segregation. 3. Upon receipt of the completed business reply form, Stryker will contact you to arrange for the return of your product(s). 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. If you have further distributed the affected product, please notify the applicable parties at once about this recall. You may copy and distribute this notification letter. a. If possible, inform us if any of the subject devices have been distributed to other organizations, including contact details so that we can inform the recipients appropriately. b. If you are a distributor, note that you are responsible for notifying your affected customers." For questions or concerns, please contact [email protected]. On 03/27/2025, Stryker issued an updated notice to include and additional product via email.

Recall details

Recall number
Z-1535-2025
Status
Open, Classified
Initiated by the company
Mar 5, 2025
Posted by the FDA
Apr 8, 2025
Recalling firm
Tornier S.A.S.
Quantity
22 units
Product code
OLO
FDA submissions
K222510
Distribution
US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland

Product description

stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

Code information (models, lots, serial numbers)

All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022933

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 96437).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page