Recall Z-1481-2012 ยท FTL Mesh, Surgical, Polymeric
Coloplast Manufacturing US, LLC
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 laparo
| Date | May 2, 2012 (initiated Mar 2, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root 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 | 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. |
| FDA record | Open on fda.gov |