Z-2192-2025Class II

Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35

Name: Z-2192-2025 Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
Creator: Phasor Health, LLC
Published: 2025-03-21
License: https://open.fda.gov/license/

Phasor Health, LLC / initiated 2025-03-21 / Open, Classified

FDA source

Phasor Health, LLC began a recall of Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35 on 2025-03-21. FDA classified it as Class II and gives the reason as "Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2192-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-03-21
Posted: 2025-07-29
Recalling firm: Phasor Health, LLC
Product: Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Reason for recall: Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.
FDA 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 [email protected] to report results of inventory inspection and to facilitate device return. 4) Complete and return the acknowledgement and receipt form via email to [email protected] Please contact Firm at [email protected] or (832) 982-1234 for more information or questions
Quantity in commerce: 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
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2192-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2192-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-06	2025-07-29

Product code HBE

K161704Class IIPhasor DrillBiotex, Inc. / cleared 2016-12-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)