Alphatec Spine recalled 15 units of Lateral Navigation Disc Prep Instruments on January 2, 2026, due to a design flaw. The navigated array connection geometry is incorrect, posing risks during surgical procedures. Healthcare providers and patients should stop using the instruments 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 instruments include the ATEC Lateral Navigation Disc Prep Instruments, REF 267-01-000-10-N. They are intended for surgical procedures and can be non-sterile or sterile packaged. The instruments were distributed nationwide in various states including AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
A design issue affects the navigated array connection geometry, which could lead to improper functionality during surgical procedures. This flaw can increase the risk of surgical complications.
No specific injuries or incidents have been reported as a result of this design flaw. However, the potential for harm exists during surgical use.
Stop using the ATEC Lateral Navigation Disc Prep Instruments immediately. Follow the recall instructions from Alphatec Spine, Inc. Healthcare providers should contact the manufacturer for further guidance.
For more information, contact Alphatec Spine, Inc. or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1343-2026.
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