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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 Stapler see related information
Date Initiated by Firm March 19, 2015
Date Posted April 29, 2015
Recall Status1 Terminated 3 on July 08, 2015
Recall Number Z-1545-2015
Recall Event ID 70906
510(K)Number K024117  K033602  K061784  K090159  K120373  
Product Classification Staple, implantable - Product Code GDW
Product Insorb 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
Recalling Firm/
Manufacturer		 Incisive Surgical Inc
14405 21st Ave N
Plymouth MN 55447-4685
For Additional Information Contact customer 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
Action Firm is working with EU Rep on English and Turkish notification letters.
Quantity in Commerce 210 cartons (containing 6 INSORB staplers per carton)
Distribution International Distribution Only - Turkey.
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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