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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 24, 2016
Date Posted December 01, 2016
Recall Status1 Terminated 3 on April 11, 2017
Recall Number Z-0690-2017
Recall Event ID 75627
510(K)Number K141484  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product FMsealer Open Shears. Model FM3001
Code Information Lots: 153411; 160321; 160531; 160991; 161311; 161442; 161871; 162091
Recalling Firm/
Manufacturer		 Domain Surgical, Inc.
1370 S 2100 E
Salt Lake City UT 84108-2244
For Additional Information Contact Holley Moss
801-924-4950
Manufacturer Reason
for Recall		 Domain Surgical, Inc. announces a voluntary field action for the FMsealer Open Shears due to fixed jaw fractures during clincal usage.
FDA Determined
Cause 2		 Other
Action Consignees were notified on 10/24/2016 via letter to return affected products to Domain Surgical, Inc.
Quantity in Commerce 70 units US; 175 units OUS
Distribution Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
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 = GEI and Original Applicant = DOMAIN SURGICAL, INC.
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