Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
Recall
- Recall Number
- Z-2192-2025
- Event Number
- 97089
- Firm
- Phasor Health, LLC
- FEI Number
- 3016577622
- Product Code
- HBE
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- March 21, 2025
- Posted
- July 29, 2025
- Address
- 8944 Kirby Dr, Houston, TX, 77054-2829
Description
Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
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 [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
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