Recall Z-1341-2013— Coloplast Manufacturing US, LLC

Name: FDA recall Z-1341-2013
Creator: U.S. Food and Drug Administration
Published: 2013-04-12

Class II · Terminated

Class II FDA medical device recall by Coloplast Manufacturing US, LLC, initiated 2013-04-12, terminated 2014-01-21. It names one FDA 510(k) clearance: K122440. Product: Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.. Reason: 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..

Recalling firm: Coloplast Manufacturing US, LLC
Classification: Class II
Status: Terminated
Initiated: 2013-04-12
Terminated: 2014-01-21
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K122440 — RESTORELLE LColoplast Corp.·cleared 2012-11-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.