Recall Z-0937-2026 ยท OLO Orthopedic Stereotaxic Instrument
SEASPINE ORTHOPEDICS CORPORATION
Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-400145; Navigation, 5.5mm Drill, REF: PC2-400155; Navigation, 3.5mm Tap, REF: PC2-400235; Navigation, 4.0mm Tap, REF: PC2-400
| Date | Dec 17, 2025 (initiated Nov 17, 2025) |
| Status | Open, Classified |
| Reason | The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only. |
| Root cause | Labeling design |
| Action | On 10/27/2025, device correction notices were emailed to customers who were informed of the following: The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic's Solera and Medtronics Infinity system StealthStation tool cards as compatible with the NorthStar OCT Navigation Instruments; however, the NorthStar OCT Navigation Instruments are indicated for use with Medtronic's Solera tool cards only. 1) Discontinue use of Medtronic's Infinity tool cards with NorthStar OCT Navigation instruments. 2) Discard affected version of the Surgical Technique Guide |
| Quantity | 310 |
| Distribution | US: CT, TX, NV, CO, CA, WA, NJ, OR, IN, MI, FL, PA, IL, VA, AL, RI, MO, AZ, MS, SC, UT, NY, OK, SD. OUS: Australia, Mexico, Chile |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172517 | SeaSpine Navigation System SeaSpine Orthopedics Corporation, May 11, 2018 |