Rostorelle L — Class II medical device recall Z-1341-2013
Terminated recall by Coloplast Manufacturing US, LLC, reported 2013-05-29, distributed nationwide. Coloplast is recalling one lot of Restorelle L prosthesis because it is mislabeled. The incorrect Instructions
| Recall number | Z-1341-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Coloplast Manufacturing US, LLC, Minneapolis, MN, United States |
| Recall initiated | 2013-04-12 |
| Classified | 2013-05-20 |
| Reported by FDA | 2013-05-29 |
| Terminated | 2014-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 111 |
| Reason classes | labeling |
| Model numbers | 501440 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1341-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.