Phasor neurosurgical drills may have a reverse battery orientation
The Phasor Drill, used in neurosurgical procedures, is being recalled because it may have a reverse battery orientation, which may increase surgical time. 1,064 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall where the stated consequence is increased surgical time rather than any patient injury or device malfunction in use.
Plain-English summary
The Phasor Drill, REF 2.70S, 3.20L, 4.50, 5.30 and 6.35, is being recalled. The action covers 1,064 units across the UDI-DI codes and lot numbers listed in the recall notice.
The stated reason is that the drill, for use in neurosurgical procedures, may have a reverse battery orientation, which may increase surgical time. The FDA classified the action as Class II. The source does not describe a patient injury.
Distribution was in Pennsylvania, Indiana, Arizona, Missouri, Louisiana, Florida, Texas, Massachusetts, Ohio and Tennessee among other states and Guam. The drills are supplied to surgical facilities rather than sold to consumers.
Facilities should identify affected stock using the REF, UDI-DI and lot numbers in the recall notice and follow the instructions issued by the manufacturer.
The recalled product
- Product
- Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
- Manufacturer
- Phasor Health, LLC
- Category
- Medical Device — Surgical drill
- Affected units
- 1,064
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UDI-DI: B775270S0
- B775320L0
- B7754500
- B7755300
- B7756350. Lot: 241002450
- 241002530
- 241009450
- 241009530
- 241016450
- 241016530
- 241023450
- 241023530
- 241030450
- 241030530
- 24112027S
- 24121827S
- 24122727S
- 25012227S
- 24082832L
- 24102332L
Distribution
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