Recall record at a glance
| Official record | Z-1540-2025 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Tornier S.A.S. |
| Report date | Apr 16, 2025 |
| Recall initiation date | Mar 5, 2025 |
| Quantity | 474 units |
| Location | Montbonnot-Saint-Martin, N/A, France |
Official product description
stryker Blueprint Mixed Reality Depth Stop Pin, Catalog Number MRUE206; Total Shoulder Arthroplasty
Why the product was recalled
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.
Distribution information
US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.