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U.S. Department of Health and Human Services

Class 2 Device Recall Blueprint Mixed Reality system

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 Class 2 Device Recall Blueprint Mixed Reality systemsee related information
Date Initiated by FirmMarch 05, 2025
Date PostedApril 08, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1540-2025
Recall Event ID 96437
510(K)NumberK222510 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Productstryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
Code Information All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022988
Recalling Firm/
Manufacturer		 Tornier S.A.S.
161 Rue Lavoisier
Montbonnot-Saint-Martin France
For Additional Information ContactMeghan Wells
901-201-9298
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionStryker 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 memphis.fieldaction@stryker.com. On 03/27/2025, Stryker issued an updated notice to include and additional product via email.
Quantity in Commerce474 units
DistributionUS: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OLO
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