Recall Z-0006-04 ยท FTR Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
Inamed Corp
McGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561
| Date | Oct 15, 2003 (initiated Sep 12, 2003) |
| Status | Terminated |
| Reason | The 400cc, 460cc, 500cc and 560cc sizes of the McGhan Style 40 Silicone-filled Breast Implants were manufactured using one size smaller shells than required. |
| Root cause | Other |
| Action | Recall was by letter to surgeons on 9/12/2003 which ask for return of unimplanted devices and an accounting of what is to be returned. |
| Quantity | 694 |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.