Alphatec Spine, Inc. is recalling 22 units of its ATEC Lateral Navigation Disc Prep Instruments, specifically 10mm osteotomes used in surgical procedures. The recall was initiated because a design issue caused the connection geometry for the navigated array to be incorrect. These instruments are designed to function with the Medtronic StealthStation System and NavLock Tracker; the geometry error may lead to inaccuracies during guided surgical procedures. Consumers and healthcare facilities should stop using the affected instruments and contact the manufacturer to arrange for their return or replacement.
The incorrect connection geometry on the instrument's navigated array can cause navigational inaccuracies during spinal surgery. This defect may lead to improper instrument placement, potentially resulting in surgical complications or patient injury.
Recall #: Z-1342-2026; Quantity: 7 units; GMDN 12844
Recall #: Z-1343-2026; Quantity: 15 units; GMDN 12844
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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