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U.S. Department of Health and Human Services

Class 2 Device Recall Phasor Drill

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 Class 2 Device Recall Phasor Drillsee related information
Date Initiated by FirmMarch 21, 2025
Date PostedJuly 29, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2192-2025
Recall Event ID 97089
510(K)NumberK161704 
Product Classification Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
ProductPhasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
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.
Recalling Firm/
Manufacturer		 Phasor Health, LLC
8944 Kirby Dr
Houston TX 77054-2829
Manufacturer Reason
for Recall		Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.
FDA Determined
Cause 2		Process change control
ActionStarting 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 in Commerce1,064
DistributionUS: 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HBE
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