ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-0...
Reason for Recall / Hazard
Due a design issue where the navigated array connection geometry is incorrect.
Product Description & Identification
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.
Affected 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.
Additional Source Details
| Field | Value |
|---|---|
| City | Carlsbad |
| State | CA |
| Event id | 98251 |
| Address 1 | 1950 Camino Vida Roble |
| Address 2 | N/A |
| Code info | Model/Catalog Number: 267-01-000-10-N UDI-DI code: 00190376541471 Lot Number: EM56693 |
| Postal code | 92008-6505 |
| Report date | 20260218 |
| Product type | Devices |
| Product quantity | 15 units |
| Reason for recall | Due a design issue where the navigated array connection geometry is incorrect. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260102 |
| Initial firm notification | Letter |
| Center classification date | 20260211 |
Overview
- Recalling FirmAlphatec Spine, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide distribution in the states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.