Class 2 Device Recall Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device

• Date Initiated by Firm: December 29, 2010
• Date Posted: February 18, 2011
• Recall Status: Terminated on November 07, 2012
• Recall Number: Z-1260-2011
• Recall Event ID: 57567
• 510(K)Number: K093845
• Product Classification: Implantable Staple - Product Code GDW
• Product: Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25. Intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as hernia repairs.
• Code Information: All Lots. Batch Numbers: CJM838,CJZ014, CJZ065, CJZ228, CJZ456, CJZ542, CJZ625, CJ6116, CJ6293, CJ6402, CJ6572, CJ6852, CJK043, CJK216, CJK330, CJK536, CJK659, CKM791, CKZ068, CKZ437, CKZ652, and CK6002.
• FEI Number: 2210968
• Recalling Firm/ Manufacturer: Ethicon, Inc.; US Highway 22 West; Somerville NJ 08876
• For Additional Information Contact: Iris Magalhaes; 908-218-3044
• Manufacturer Reason for Recall: The Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device may have the potential for the sterile barrier to be compromised due to a defect in the packaging.
• FDA Determined Cause: Pending
• Action: Ethicon sent Urgent Voluntary Product Recall letters dated, December 28, 2010, to their customers on December 29, 2010 via UPS. The letter identified the affected product and described the reason for recall. Customers are to discontinue use and sampling immediately. They are to return the product using the enclosed prepaid shipping label along with the enclosed business reply card regardless of whether they have any affected product or not. Customers should contact 1-877-551-7147 or speak to their manager if they have questions regarding this recall.
• Quantity in Commerce: 4,110
• Distribution: Worldwide Distribution -- USA and Canada.
• 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