FDA Medical Device Recalls (openFDA)
Phasor Health, LLC: Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
- Recall number
- Z-2192-2025
- Recalling firm
- Phasor Health, LLC
- Product
- Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
- Status
- Open, Classified
- Initiated
- 2025-03-21
- Posted
- 2025-07-29
- Terminated
- not on file
- 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 (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
- 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
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K161704"]
- PMA numbers
- not on file
- Product code
- HBE
- Firm FEI
- 3016577622
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28