Coloplast Manufacturing US, LLC: Medical Device Recall in 2013 - (Recall #: Z-1341-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 12, 2013

Date Posted: May 29, 2013

Recall Number: Z-1341-2013

Event ID: 64943

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.

Status: Terminated

Product Quantity: 111

Code Information:

3483171

Distribution Pattern:

Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA.

Voluntary or Mandated:

Voluntary: Firm initiated