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U.S. Department of Health and Human Services

Class 2 Device Recall SXOne MicroKnife

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  Class 2 Device Recall SXOne MicroKnife see related information
Date Initiated by Firm June 29, 2022
Create Date July 15, 2022
Recall Status1 Terminated 3 on April 14, 2023
Recall Number Z-1387-2022
Recall Event ID 90520
510(K)Number K192873  
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product SX-One MicroKnife
Code Information Part Number 600112-001; UDI-DI: 00860002094700; Lot Codes: 20013120, 20022821, 20022822, 20022823, 20022824, 20022825, 20070603, 20070604, 20080435, 20080436, 20083114, 20083115, 40051, 40052, 40472, 40473, 40892, 40893, 41460, 41584, 41585.
Recalling Firm/
Manufacturer		 SONEX HEALTH LLC
950 Blue Gentian Rd
Eagan MN 55121-1576
For Additional Information Contact Kari Cierzan
651-683-5060
Manufacturer Reason
for Recall		 Potential of dull blade
FDA Determined
Cause 2		 Process control
Action On 06/29/2022, Sonex Health notified consignees of the recall via emailed letter titled, "URGENT MEDICAL DEVICE RECALL." The letter instructed consignees to check inventory for affected devices, cease use of the devices and remove them from point of use, notify all applicable personnel or recipients if the product was further distributed or transferred, complete and return the provided response form, and arrange for the return of affected devices.
Quantity in Commerce 3,752 devices
Distribution US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, ID, IN, KS, MD, MI, MN, MT, NE, NJ, NV, NY, OH, OK, OR, PA, TX, UT, VA, WI, WV, WY.
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LXH and Original Applicant = Sonex Health, Inc.
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