Recall Z-2192-2025 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Phasor Health, LLC
Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
| Date | Jul 29, 2025 (initiated Mar 21, 2025) |
| Status | Open, Classified |
| Reason | Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time. |
| Root cause | Process change control |
| Action | Starting on 3/21/2025, device correction and removal began and a correction and removal notice was emailed. Customers were asked to do the following: 1) Review inventory (without opening the sterile transparent barrier) to determine if any of the affected lots remain in inventory. If yes, remove those lots from inventory. Do not use drills with reverse battery orientation. 2) If unable to review inventory soon, the Company will come to your site within 30 business days of this letter and inspect your inventory (within 20 minutes total) and replace any defective drills with new verified stock |
| Quantity | 1,064 |
| Distribution | US: PA, IN, AZ, MO, LA, FL, TX, MA, OH, TN, MI, WV, VA, CA, DE, NH, GA, SC, GU, NY, NJ, MN, WI, NE, WA, IL, AR, PR, VT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161704 | Phasor Drill Biotex, Inc., Dec 1, 2016 |