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Recall Observatory FDA recall evidence

Device product

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

Z-2192-2025

March 21, 2025

Class II

Product summary

Firm
Phasor Health, LLC
Event
Event 97089
Status
Ongoing
Classification
Class II
Quantity
1,064
Official record key
device-enforcement:Z-2192-2025

Official wording

Reason: Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.

Code information: 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.

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.