Recall Z-1537-2025 ยท OLO Orthopedic Stereotaxic Instrument
Tornier S.A.S.
stryker Blueprint Mixed Reality Instrument Check Block, Catalog Number MRUE203, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty
| Date | Apr 8, 2025 (initiated Mar 5, 2025) |
| Status | Open, Classified |
| Reason | 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 | 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 retur |
| Quantity | 17 units |
| Distribution | US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222510 | Blueprint Mixed Reality system Tornier S.A.S., Jan 20, 2023 |