Stryker Blueprint Mixed Reality Instrument Check Block Recall
Tornier S.A.S. is recalling the Stryker Blueprint Mixed Reality Instrument Check Block (Catalog Number MRUE203) due to an elevated complaint rate involving software and instrumentation malfunctions that prevent the system from functioning as intended.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a medical device used in surgical procedures where functional failures prevent intended use during patient care. Although no illnesses or injuries are explicitly reported in the source text, the product is a surgical guidance system whose malfunction during a procedure poses a direct risk of harm in the surgical context.
Plain-English summary
Tornier S.A.S. is recalling the Stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in the Stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN, used in Total Shoulder Arthroplasty procedures. The recall affects 17 units distributed in the United States (Texas, Minnesota, Alaska, Pennsylvania, Massachusetts, Tennessee, and Idaho) as well as France, Canada, and Ireland. Distribution occurred between August 23, 2023, and December 31, 2024.
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system. The complaints are multifactorial but in each instance prevent the system from meeting its intended use. The most commonly reported complaints involved impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
Affected users should contact Tornier S.A.S. or Stryker for guidance on system inspection, troubleshooting, or replacement options.
The recalled product
- Product
- stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- Manufacturer
- Tornier S.A.S.
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All lots manufactured through Oct 2024
- Distributed 23-Aug-2023 through 31-Dec-2024
- GTIN 03700434022957
Distribution
Part of a larger recall action
This product is one of 9 recalled by Tornier S.A.S. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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