Alphatec Spine recalled 7 units of Lateral Navigation Disc Prep Instruments on January 2, 2026, due to a design flaw. The incorrect navigated array connection geometry poses a high hazard risk in surgical settings. Healthcare providers and patients must stop using the devices immediately.
Due a design issue where the navigated array connection geometry is incorrect.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Alphatec Spine, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the ATEC Lateral Navigation Disc Prep Instruments, specifically the LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N. These instruments are designed for surgical procedures and may be sterile or non-sterile. They were distributed nationwide in the U.S. states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
The recall stems from a design issue where the navigated array connection geometry is incorrect. This defect could significantly impact surgical procedures, leading to serious complications.
There are no reported injuries or deaths associated with this recall as of now. The potential danger, however, remains high due to the critical nature of the device's intended use.
Patients and healthcare providers should immediately stop using the affected instruments. Contact Alphatec Spine, Inc. or your healthcare provider for further instructions and follow the recall instructions provided.
For more information, contact Alphatec Spine, Inc. or visit the FDA website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1342-2026.
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