Class 2 Device Recall Stryker Blueprint

• Date Initiated by Firm: December 18, 2024
• Date Posted: January 10, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0846-2025
• Recall Event ID: 96030
• 510(K)Number: K222510
• Product Classification: Orthopedic stereotaxic instrument - Product Code OLO
• Product: Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
• Code Information: UDI/DI 03700434022926, Lot Numbers: 22A796, 22A797, 22A978, and 22A979
• Recalling Firm/ Manufacturer: Tornier S.A.S.; 161 Rue Lavoisier; Montbonnot-Saint-Martin France
• For Additional Information Contact: Meghan Wells; +33 06 63750024
• Manufacturer 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.
• FDA Determined 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 memphis.fieldaction@stryker.com 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OLO