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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 STAPLERsee related information
Date Initiated by FirmAugust 29, 2018
Create DateOctober 05, 2018
Recall Status1 Terminated 3 on March 18, 2019
Recall NumberZ-0078-2019
Recall Event ID 81008
510(K)NumberK120373 
Product Classification Staple, implantable - Product Code GDW
ProductINSORB 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
ActionThe 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 Commerce1200 units
DistributionIsrael
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = GDW
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