Recall Z-1341-2013 ยท OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Coloplast Manufacturing US, LLC
Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.
| Date | May 20, 2013 (initiated Apr 12, 2013) |
| Status | Terminated |
| 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. |
| Root cause | Labeling mix-ups |
| Action | Coloplast sent a letter to dated April 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The letter included an attachment with the correct IFU to replace the incorrect IFU. Customers with questions were instructed to call Customer Service at 800-258-3476. For questions regarding this recall call 612-302-4992. |
| Quantity | 111 |
| Distribution | Nationwide Distribution including AL, CA, CO, DC, IL, IN, KY, MD, MA, MO, NH, OH, RI, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122440 | RESTORELLE L Coloplast Corp., Nov 19, 2012 |