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.
FDA Recall Z-1481-2012 · Posted 2012-05-02
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Recalling FirmColoplast Manufacturing US, LLC
Recall StatusTerminated
Product CodeFTL
Date Initiated2012-03-02
Date Terminated2012-10-11
Product Quantity134
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.
Firm 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.
Root Cause
Error in labeling
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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