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U.S. Department of Health and Human Services

Class 3 Device Recall Restorelle DirectFix Posterior Mesh

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 Class 3 Recall
Restorelle DirectFix Posterior Mesh
see related information
Date Posted May 02, 2012
Recall Status1 Terminated on October 11, 2012
Recall Number Z-1481-2012
Recall Event ID 61411
Premarket Notification
510(K) Numbers
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, Minnesota 55411-3431
Consumer Instructions Contact the recalling firm for information
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 2
PRODUCTION CONTROLS: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FTL and Original Applicant = COLOPLAST A/S
510(K)s with Product Code = FTL and Original Applicant = MPATHY MEDICAL DEVICES, LTD.
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