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U.S. Department of Health and Human Services

Class 2 Device Recall MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture

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  Class 2 Device Recall MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture see related information
Date Initiated by Firm February 02, 2009
Date Posted May 12, 2009
Recall Status1 Terminated 3 on October 21, 2009
Recall Number Z-1312-2009
Recall Event ID 51049
510(K)Number K050845  
Product Classification Absorbable Polyglycolic Synthetic Suture - Product Code GAM
Product MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture;
Ethicon, Inc., A Johnson & Johnson Company, Somerville, NJ

Sutures are intended for general soft tissue approximation and/or ligation.
Code Information Lot number  APZ486,  APZ352, and  APZ414.  
Recalling Firm/
Ethicon, Inc.
US Highway 22 West
Somerville NJ 08876
For Additional Information Contact Christiana Bielinski
Manufacturer Reason
for Recall
Sterility Issue: The firm decided to remove the product because it cannot assure the sterility of the products due to a failure in the sterilization process.
FDA Determined
Cause 2
Process control
Action Urgent Voluntary Product Recall notification letters were sent via UPS Next Day Air with receipt on February 2, 2009. Letters were sent to customers, Directors of Surgical Services, Director of Risk Management, Materials Manager and Distributors. The letters requested that customers immediately discontinue use of the products with lot numbers listed. Customers are to identify and return only the boxes identified in the attached tables. The affected product should be returned to Ethicon via the pre-paid authorized shipping label. Customers that are not returning affected product should mail the enclosed business reply card to Ethicon. Customers should direct questions regarding this recall to 1-888-202-3694 or their Ethicon sales representative. 5/13/09: It was discovered that a lot of PDS II sutures that had been previously identified as affected but not distributed, were mistakenly distributed. Revised letters including this number were sent to 25 customers on 5/13/09.
Quantity in Commerce 1,758,360 total
Distribution Worldwide Distribution -- USA, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Greece, Hong Kong, Israel, Japan, Korea, Luxemburg, Mexico, New Zealand, Norway, Panama, Puerto Rico, Sweden, Taiwan, United Kingdom, Uruguay, and Venezuela.
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 = GAM and Original Applicant = ETHICON, INC.