Class 3 Device Recall Restorelle DirectFix Posterior Mesh

• Date Initiated by Firm: March 02, 2012
• Date Posted: May 02, 2012
• Recall Status: Terminated on October 11, 2012
• Recall Number: Z-1481-2012
• Recall Event ID: 61411
• 510(K)Number: K041632 K053361 K103568
• Product Classification: Mesh, surgical, polymeric - Product Code FTL
• Product: Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx Only, Manufacturer, Coloplast A/S 3050 Denmark Restorelle is a ploypropylene mesh that may be used for the repair of abdominal wall hernia, including inguinal, fermoral, and incisional, and uterovaginal proplapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.
• Code Information: Lot numbers : 2936642, 2967400.
• Recalling Firm/ Manufacturer: Coloplast Manufacturing US, LLC; 1601 W River Rd; Minneapolis MN 55411-3431
• For Additional Information Contact: 612-302-4992
• Manufacturer Reason for Recall: Coloplast is conducting a field correction based on the conclusion that two lots of Restorelle DirectFix Posterior mesh were mislabeled. The incorrect size was printed on the patient label. Specifically the patient label depicts the size as 16x11 cm, however, the correct size is actually 14x15 cm. It is important to note that both the product and box labels were correct.
• FDA Determined Cause: Error in labeling
• Action: Coloplast sent a notification letter dated March 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed their coloplast representative is providing replacement device (s) and new patient labels. For further questions please call 1 (800) 258-3476.
• Quantity in Commerce: 134
• Distribution: USA ( nationwide) including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, KY, MD, MS, MO, NY, PA, TN, VA,WA and WI.
• 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; 510(K)s with Product Code = FTL