SeaSpine Orthopedics Corporation is recalling 310 NorthStar OCT Navigation surgical instruments and their accompanying Surgical Technique Guides. The guides incorrectly state that these instruments are compatible with Medtronic’s Infinity system toolcards, when they are only intended for use with Medtronic’s Solera toolcards. Using these instruments with the wrong system could result in navigation errors during surgery, potentially leading to incorrect hardware placement and serious patient injury.
The incorrect compatibility information in the surgical guide may cause surgical teams to use the navigation instruments with unsupported system toolcards. This can lead to inaccurate real-time data during surgery, potentially causing surgical delays or serious patient injuries if spinal hardware is incorrectly placed.
Guide incorrectly identified compatibility with Medtronic Infinity system toolcards.
No lots released.
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.
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Sources: FDA iRES · Raw API Response
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