Recall Z-2192-2025
Phasor Health, LLC · initiated March 21, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
Codes / lots: UDI-DI: B775270S0, B775320L0, B7754500, B7755300, B7756350. Lot: 241002450, 241002530, 241009450, 241009530, 241016450, 241016530, 241023450, 241023530, 241030450, 241030530, 24112027S, 24121827S, 24122727S, 25012227S, 24082832L, 24102332L, 241227450, 241220635, 250122635, 241227530, 250122530.
Reason for recall
Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.
FDA-determined cause: Process change control
Action taken
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 (same catalog number). 3) Contact firm at info@phasorhealth.com to report results of inventory inspection and to facilitate device return. 4) Complete and return the acknowledgement and receipt form via email to info@phasorhealth.com Please contact Firm at info@phasorhealth.com or (832) 982-1234 for more information or questions
Details
- Recall number
- Z-2192-2025
- Initiated
- March 21, 2025
- Posted by FDA
- July 29, 2025
- Product code
- HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered)
- 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
- Recalling firm
- Phasor Health, LLC, Houston, TX