Class 2 Device Recall Ethicon Inc.

• Date Initiated by Firm: February 19, 2014
• Date Posted: April 03, 2014
• Recall Status: Open, Classified
• Recall Number: Z-1329-2014
• Recall Event ID: 67736
• 510(K)Number: K060713
• Product Classification: Mesh, surgical - Product Code FTM
• Product: Proceed Surgical Mesh, Product Codes PCDB1, PCDT1, and PCDJ1. Ethicon Inc., Johnson & Johnson Medical GmbH, used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
• Code Information: Product Code PCDB1 - Lot number - GGG157 Product Code PCDT1 - Lot number - GGG158 Product Code PCDJ1 - Lot number -GGG159
• Recalling Firm/ Manufacturer: Ethicon, Inc.; US Highway 22 West; Somerville NJ 08876
• For Additional Information Contact: 908-218-0707
• Manufacturer Reason for Recall: The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.
• FDA Determined Cause: Under Investigation by firm
• Action: Ethicon sent an Urgent Medical Device Recall letter dated February 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to examine their inventory and determine if they have any of the affected product. If any product has been distributed, those hospitals should be notified. The business reply form should be completed and faxed or emailed to Stericycle at 1-888-641-9732 or ethicon5798@stericycle.com. For clinical or product support contact a customer representative or call the Customer Support Center at 1-877-ETHICON to speak with a registered nurse or contact Stericycle at 1-888-345-0524 and reference event #5798. Stericycle is handling returns.
• Quantity in Commerce: 223 units
• Distribution: US Distribution including the states of FL, NJ, MO, IL, PA, NC. TX, TN, WA, ID, UT, WV, MS. CA, AL, MA. GA, LA and OK.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FTM