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Blueprint Mixed Reality recallZ-0846-2025 · Tornier S.A.S. · initiated Dec 18, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Tornier S.A.S. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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

Recall details

Recall number
Z-0846-2025
Status
Open, Classified
Initiated by the company
Dec 18, 2024
Posted by the FDA
Jan 10, 2025
Recalling firm
Tornier S.A.S.
Quantity
24 units
Product code
OLO
FDA submissions
K222510
Distribution
US: MN, KY, MD, MA, TX, AK, TX, ID; France, Canada

Product description

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

Code information (models, lots, serial numbers)

UDI/DI 03700434022926, Lot Numbers: 22A796, 22A797, 22A978, and 22A979

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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