Recall Z-0336-06 ยท FWM Prosthesis, Breast, Inflatable, Internal, Saline
Inamed Corp
McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
| Date | Dec 31, 2005 (initiated Dec 14, 2005) |
| Status | Terminated |
| Reason | Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these two lots were switched during packaging. As a result, a total of 40 devices were mislabeled. |
| Root cause | Other |
| Action | On Wednesday, 14-December-2005, Inamed began calling affected customers to notify them of the voluntary recall. At the end of business on Wednesday, 14-December-2005, Inamed distributed Recall Notification Letters via Federal Express overnight mail directly to affected customers. |
| Quantity | 18 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.