Z-1341-2013Class II

Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark

Name: Z-1341-2013 Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark
Creator: Coloplast Manufacturing US, LLC
Published: 2013-04-12
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2013-04-12 / Terminated / root cause: labeling and UDI

FDA source

Coloplast Manufacturing US, LLC began a recall of Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark on 2013-04-12. FDA classified it as Class II and gives the reason as "Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging". 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-1341-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-12
Posted: 2013-05-20
Terminated: 2014-01-21
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
Product code: OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Reason for recall: Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions For Use (IFU) pamphlet is included in the packaging.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Coloplast sent a letter to dated April 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter included an attachment with the correct IFU to replace the incorrect IFU. Customers with questions were instructed to call Customer Service at 800-258-3476. For questions regarding this recall call 612-302-4992.
Quantity in commerce: 111
Distribution: Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA.
Product codes and lots: 3483171

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1341-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1341-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-20

Product code OTO

K122440Class IIRestorelle LColoplast Corp. / cleared 2012-11-19

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)