Recall Z-0846-2025 ยท OLO Orthopedic Stereotaxic Instrument
Tornier S.A.S.
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
| Date | Jan 10, 2025 (initiated Dec 18, 2024) |
| Status | Open, Classified |
| Reason | The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional. |
| Root cause | Device Design |
| Action | Stryker issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 12/18/2024 via email. The notice explained the problem with the device and requested the following actions be taken: "1. Review the product issue as communicated in this Recall Notice & communicate the issue as appropriate in your organization. 2. Locate and isolate/quarantine the affected device to prevent accidental use pending return. 3. Please use a device from a conforming lot for all procedures. 4. Return the enclosed business reply form by email to confirm receipt of this notification. a. Response is required, eve |
| Quantity | 24 units |
| Distribution | US: MN, KY, MD, MA, TX, AK, TX, ID; France, Canada |
| 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 |