stryker HoloBlueprint Application, Catalog Number MRUE001; Total Shoulder Arthroplasty
FDA device recall Z-1542-2025 · posted 2025-04-08 · Open, Classified
Recall details
- Recalling firm
- Tornier S.A.S.
- 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.
- Action taken
- 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 memphis.fieldaction@stryker.com. On 03/27/2025, Stryker issued an updated notice to include and additional product via email.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OLO
- Quantity affected
- 14
- Distribution
- US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
- Date initiated
- 2025-03-05
- Date posted
- 2025-04-08
- Location
- Montbonnot-Saint-Martin, France
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Blueprint Mixed Reality system (K222510) | Tornier S.A.S. | 2023-01-20 |