Reported May 29, 2013 · Terminated
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
Coloplast Manufacturing US, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Coloplast Manufacturing US, LLC · 1601 W River Rd · Minneapolis, MN · 55411-3431
Is this the product you have?
- Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
- Lot codes and dates
- 3483171
- Amount recalled
- 111
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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