Phasor Health, LLC recalls Phasor Drill

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

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

• FDA enforcement recordOfficial FDA database entry for Z-2192-2025
• FDA 510(k) clearance · K161704The device's official FDA premarket clearance record
• FDA device classification · HBEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.4310The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Phasor Health, LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.