Z-1481-2012

Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx Only...

Name: Z-1481-2012 Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx Only...
Creator: Coloplast Manufacturing US, LLC
Published: 2012-03-02
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2012-03-02 / Terminated / root cause: labeling and UDI

FDA source

Coloplast Manufacturing US, LLC began a recall of Coloplast, Restorelle DirectFix, Posterior Polypropylene Mesh, Catalogue Number 501460, Rx Only, Manufacturer, Coloplast A/S 3050 Denmark Restorelle is a... on 2012-03-02. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1481-2012
Status: Terminated
Initiated: 2012-03-02
Posted: 2012-05-02
Terminated: 2012-10-11
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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.
Product code: FTL Mesh, Surgical, Polymeric
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.
Root cause tag: labeling and UDI
FDA 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 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.
Product codes and lots: Lot numbers : 2936642, 2967400.

Product code FTL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)