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U.S. Department of Health and Human Services

Class 2 Device Recall INSORB 2030 Subcuticular Skin Stapler

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 Class 2 Device Recall INSORB 2030 Subcuticular Skin Staplersee related information
Date Initiated by FirmMarch 19, 2015
Date PostedApril 29, 2015
Recall Status1 Terminated 3 on July 08, 2015
Recall NumberZ-1545-2015
Recall Event ID 70906
510(K)NumberK024117 K033602 K061784 K090159 K120373 
Product Classification Staple, implantable - Product Code GDW
ProductInsorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by hydrolysis to glycolic acid and lactic acid which are then absorbed and metabolized by the body.
Code Information Lot 121901
FEI Number 3004028675
Recalling Firm/
Manufacturer		 Incisive Surgical Inc
14405 21st Ave N
Plymouth MN 55447-4685
For Additional Information Contactcustomer service
952-591-2543 Ext. 032
Manufacturer Reason
for Recall		A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. The expiration date at the time of manufacturing was 2014-05.
FDA Determined
Cause 2		Labeling False and Misleading
ActionFirm is working with EU Rep on English and Turkish notification letters.
Quantity in Commerce210 cartons (containing 6 INSORB staplers per carton)
DistributionInternational Distribution Only - Turkey.
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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