Z-1341-2013 Class II Terminated
FDA device recall Z-1341-2013 was initiated by Coloplast Manufacturing US, LLC on Apr 12, 2013 and is designated Class II. 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. The recall status is terminated (terminated Jan 21, 2014). Affected quantity: 111.
Recall Details
- Product Type
- Devices
- Report Date
- May 29, 2013
- Initiation Date
- Apr 12, 2013
- Termination Date
- Jan 21, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 111
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.
Distribution Pattern
Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA.
Code Information
3483171
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1341-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026