This recall affects 24 units of the Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide (Model MRUE200) manufactured in France and used during total shoulder replacement surgeries. The recall was initiated because the metal tube on the guide can detach from its plastic handle, which prevents the Mixed Reality headset from tracking the device properly. No injuries have been reported, but this defect could cause surgical delays or require the surgeon to switch from a guided surgical method to a conventional one. Facilities should stop using these guides and contact the manufacturer or their distributor to arrange for a return or replacement.
If the metal tube disassembles from the handle during surgery, the system will lose its ability to track the guide, potentially prolonging the time a patient is under anesthesia or forcing the surgeon to change their surgical approach mid-procedure.
Indicated for use during Total Shoulder Arthroplasty.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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