Z-1541-2025Class II
stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
Tornier S.A.S. / initiated 2025-03-05 / Open, Classified / root cause: design
Tornier S.A.S. began a recall of stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1541-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Tornier S.A.S.
- Product
- stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
- Product code
- OLO Orthopedic Stereotaxic Instrument
- Reason for recall
- 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.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- 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.
- Distribution
- US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
- Product codes and lots
- All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN x
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1534-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1535-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1536-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1537-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1538-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1539-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1540-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1541-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1542-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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