Recall Z-1342-2026 ยท OLO Orthopedic Stereotaxic Instrument
Alphatec Spine, Inc.
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.
| Date | Feb 11, 2026 (initiated Jan 2, 2026) |
| Status | Open, Classified |
| Reason | Due a design issue where the navigated array connection geometry is incorrect. |
| Root cause | Device Design |
| Action | On 01/02/2026, the firm emailed an "URGENT-MEDICAL DEVICE RECALL NOTIFICATION" Letter to customers informing them that Alphatec Spine has been notified of complaints regarding LIF Navigated Osteotome instruments appearing to have incorrect orientation when used with the Medtronic StealthStation". The instrument is correctly identified and displays the correct navigated length; however, the projected image on the Medtronic StealthStation" is rotated by 90. Customers are instructed to: "Review their inventory to determine if any of these affected devices are in their possession. If a device is |
| Quantity | 7 units |
| Distribution | U.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223765 | ATEC Lateral Navigation Instruments Alphatec Spine, Inc., Mar 23, 2023 |