Z-0846-2025Class II

Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total...

Name: Z-0846-2025 Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total...
Creator: Tornier S.A.S.
Published: 2024-12-18
License: https://open.fda.gov/license/

Tornier S.A.S. / initiated 2024-12-18 / Open, Classified / root cause: design

FDA source

Tornier S.A.S. began a recall of Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty on 2024-12-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0846-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-18
Posted: 2025-01-10
Recalling firm: Tornier S.A.S.
Product: Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: 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 tag: design
FDA 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, even if you may not have any physical inventory on site anymore. It may be that you no longer have any physical inventory on site. Completing this form will allow us to update our records and will also negate the need for us to send any further unnecessary communications on this matter. Therefore, please complete even if you no longer have any of the subject devices in your physical inventory. 5. Please ensure that all potential users of these products within your facility are made aware of this notification 6. Please complete the attached response form and return it to [email protected] so we may arrange for the return of the affected unit(s). 7. Maintain awareness of this communication internally until all required actions have been completed within your facility." Actions for distributors are as follows: "8. If you have further distributed the affected product, please notify your customers 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. 9. Please inform us of any adverse event and/or report them to the Health/Competent Authorities in accordance with c
Quantity in commerce: 24 units
Distribution: US: MN, KY, MD, MA, TX, AK, TX, ID; France, Canada
Product codes and lots: UDI/DI 03700434022926, Lot Numbers: 22A796, 22A797, 22A978, and 22A979

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0846-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0846-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-10

Product code OLO

K222510Class IIBlueprint Mixed Reality systemTornier S.A.S. / cleared 2023-01-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)