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U.S. Department of Health and Human Services

Class 2 Device Recall autosuture

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  Class 2 Device Recall autosuture see related information
Date Initiated by Firm December 15, 2010
Date Posting Updated February 01, 2011
Recall Status1 Terminated 3 on January 10, 2013
Recall Number Z-1009-2011
Recall Event ID 57576
510(K)Number K915526  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product AutoSuture SURGIPRO Polyproylene Mesh Clear 3" x 5" Sterile
REF SPM 35

Surgipro Flat Sheet mesh is a non-absorbable, polypropylene surgical mesh exhibiting high burst strength and tensile strength. Surgipro comes in multiple designs, including multi-filament and open weave. All designs are knitted in such a fashion as to provide bi-directional elasticity, while allowing the mesh to be cut to any shape without unraveling.
Mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a non-absorbable mesh during and after wound healing.
Code Information Lot Number: A0K0490, Exp Date: 2015-10
Recalling Firm/
Manufacturer
Covidien LP
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information Contact Same
203-492-5000
Manufacturer Reason
for Recall
Sterility compromised due to breach in sterile barrier
FDA Determined
Cause 2
Packaging process control
Action Covidien notified customers via letter dated November 15, 2010. The letter identified the product, the problem, and action to be taken by the customer. Customers were instructed to examine inventory and return the affected lot to Field Returns Department, 195 McDermott Road, North Haven, CT 06473. For questions regarding this recall call 203-492-8091.
Quantity in Commerce 132 units
Distribution Worldwide Distribution - USA including CA, CT, FL, HI, IL, IN, KS, MA, MD, MI, MN, NC, NJ, NY, OH, PA, SC, TX, and WI and the countries of Canada and Italy
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 = FTL and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
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