Class 2 Device Recall MONOCRYL (poliglecaprone 25 ) Suture

• Date Initiated by Firm: February 02, 2009
• Date Posted: May 12, 2009
• Recall Status: Terminated on October 21, 2009
• Recall Number: Z-1311-2009
• Recall Event ID: 51049
• 510(K)Number: K960653
• Product Classification: Absorbable Polyglycolic Synthetic Suture - Product Code GAM
• Product: MONOCRYL (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 # APZ334, APM964, APM965, APZ063, APZ155, APZ156, and APZ476.
• Recalling Firm/ Manufacturer: Ethicon, Inc.; US Highway 22 West; Somerville NJ 08876
• For Additional Information Contact: Christiana Bielinski; 908-218-3500
• 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: 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