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FDA-Device2026-02-18Class IIPROCESSING DEFECT

Alphatec Spine ATEC Lateral Navigation Disc Prep Osteotome recalled for connection geometry defect

Alphatec Spine
OTHERNationwide distribution

Stop using Alphatec Spine navigation osteotome

Alphatec Spine has recalled a surgical instrument (ATEC Lateral Navigation Disc Prep Osteotome 10mm) used in spine surgery procedures. The instrument has a design defect where the connection to the Medtronic navigation tracking system does not fit correctly, which could affect its safe operation during surgery.

  • If you received this instrument (Model 267-01-000-10-N, Lot EM56693), stop using it immediately.
  • Contact Alphatec Spine or your surgical facility for instructions on returning or replacing the instrument.
  • Verify with your facility that recalled units have been removed from service before any procedures.
Hazard

Due a design issue where the navigated array connection geometry is incorrect.

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
15 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 267-01-000-10-N UDI-DI code: 00190376541471; 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-1343-2026

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