FDA-Device2026-02-18Class IIPROCESSING DEFECT
Alphatec Spine ATEC Lateral Navigation Disc Prep Osteotome recalled for connection geometry defect
What this means
Alphatec Spine has recalled its ATEC Lateral Navigation Disc Prep Osteotome (10mm, model 266-01-000-10-N) used in spinal surgery due to an incorrect connection geometry in the navigated array. This defect could affect how the instrument connects to the Medtronic StealthStation navigation system during surgery. Seven units were distributed across 14 U.S. states.
- Stop using the recalled osteotome immediately if you have this instrument (model 266-01-000-10-N, lot EM49968)
- Contact your facility's medical device coordinator or Alphatec Spine for instructions on returning or replacing the instrument
- Do not use this instrument in surgical procedures until replacement or clarification is received
The agency's original wording
Hazard
Due a design issue where the navigated array connection geometry is incorrect.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
Affected count
7 units
Manufactured in
1950 Camino Vida Roble, N/A, Carlsbad, CA, United States
Products
ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1342-2026More Alphatec Spine recalls
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