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U.S. Department of Health and Human Services

Class 2 Device Recall Summit Medical

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 Class 2 Device Recall Summit Medicalsee related information
Date Initiated by FirmJanuary 13, 2023
Date PostedFebruary 24, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1171-2023
Recall Event ID 91527
Product Classification Button, nasal septal - Product Code LFB
ProductSummit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Code Information Lot #219349, Exp. 2027-11-01, UDI (01)00385640065214(17)271101(10)219340
Recalling Firm/
Manufacturer		 Summit Medical, LLC
815 Vikings Pkwy Ste 100
Eagan MN 55121-1139
For Additional Information ContactJeff Esselman
651-789-3921
Manufacturer Reason
for Recall		Sterile product pouches were not sealed.
FDA Determined
Cause 2		Process control
ActionThe firm issued "URGENT RECALL NOTICE" Letters dated 1/13/2023 via email. The letter explained the issue and requested the consignee remove the product from inventory and inspect the pouch to verify it is sealed. If the pouch is not sealed, the consignee is to cut the product with scissors and dispose of it. Results of their inspection are to be reported to the recalling firm by email using the enclosed form. A number is listed to arrange for replacement product. The consignee is to indicate on the form that they have read and understand the recall instructions, have checked their stock and disposed of inventory affected, and that they have none of the product left in inventory. If you have any questions, contact Director of Quality Assurance at 651-789-3939 or email: jesselman@innoviamedical.com.
Quantity in Commerce30 devices
DistributionUS Distribution was made to CO, FL, GA, LA, MA, and ME. There was no government/military distribution. OUS Foreign distribution was made to Canada.
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.
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