Recall Z-1216-03 ยท FWM Prosthesis, Breast, Inflatable, Internal, Saline
Inamed Corp
McGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Filled BIOCELL textured.
| Date | Sep 11, 2003 (initiated Aug 1, 2003) |
| Status | Terminated |
| Reason | Labeling mixup. |
| Root cause | Other |
| Action | Implants were requested back by telephone. They were returned at the firm''s expense. Recall is complete. |
| Quantity | 4 |
| Distribution | Tenessee. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.