Device product
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
Z-1341-2013
Product summary
- Event
- Event 64943
- Status
- Terminated
- Classification
- Class II
- Quantity
- 111
- Official record key
device-enforcement:Z-1341-2013
Official wording
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.
Code information: 3483171
Distribution pattern: Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA.
Derived failure modes
-
Labeling or packaging
mislabeled