Stryker Blueprint Mixed Reality Depth Stop Pin Recalled Due to Device Malfunction
Tornier S.A.S. is recalling 474 units of the Stryker Blueprint Mixed Reality Depth Stop Pin (Catalog Number MRUE206) due to elevated complaint rates regarding impaired software and instrumentation functioning. The malfunctions prevent the device from meeting its intended use in shoulder surgery guidance.
What this means for you
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: FDA Class II device without reported hospitalization or injuries. The device malfunction poses a risk to proper surgical guidance but no patient harm has been documented. Scored as High per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Tornier S.A.S. is recalling 474 units of the Stryker Blueprint Mixed Reality Depth Stop Pin (Catalog Number MRUE206), a surgical guidance device used in total shoulder arthroplasty procedures. The recall was initiated due to an elevated complaint rate regarding difficulties in using the Blueprint Mixed Reality Guidance Instrumentation system.
According to the manufacturer, the issues preventing proper device functioning are multifactorial. The most commonly reported complaints involve impaired software functioning, impaired instrumentation functioning, and general difficulties using the product. These problems prohibit the system from meeting its intended use.
The affected units were distributed in the United States (including Texas, Minnesota, Alaska, Pennsylvania, Massachusetts, Tennessee, and Idaho) as well as in France, Canada, and Ireland. Devices manufactured through October 2024 and distributed between August 23, 2023, and December 31, 2024, are included in the recall (GTIN 03700434022988).
Patients and surgeons who have received or are using this device should contact Tornier S.A.S. or Stryker for guidance on next steps. Healthcare providers should review usage and consider whether any corrective action is needed based on their specific circumstances.
The recalled product
- Product
- stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
- Manufacturer
- Tornier S.A.S.
- Hazard
- software-malfunction
- device-malfunction
- surgical-guidance-failure
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 03700434022988
Distribution
Distributed in 7 states:
- AK
- ID
- MA
- MN
- PA
- TN
- TX
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