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U.S. Department of Health and Human Services

Class 2 Device Recall INSORB SUBCUTICULAR SKIN STAPLER

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  Class 2 Device Recall INSORB SUBCUTICULAR SKIN STAPLER see related information
Date Initiated by Firm August 29, 2018
Create Date October 05, 2018
Recall Status1 Terminated 3 on March 18, 2019
Recall Number Z-0078-2019
Recall Event ID 81008
510(K)Number K120373  
Product Classification Staple, implantable - Product Code GDW
Product INSORB SUBCUTICULAR SKIN STAPLER, REF 2030
Code Information UDI 10867516000101 Lot Number 182801
Recalling Firm/
Manufacturer		 Incisive Surgical Inc
14405 21st Ave N Ste 130
Plymouth MN 55447-4638
Manufacturer Reason
for Recall		 Possible compromise of the sterile barrier integrity
FDA Determined
Cause 2		 Process control
Action The firm initiated the recall by telephone and email on 08/209/2018. The email notice requested that immediate suspension of all distribution. The firm will arrange to recover the product.
Quantity in Commerce 1200 units
Distribution Israel
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 = GDW and Original Applicant = INCISIVE SURGICAL, INC.
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