Recall Z-0851-05 ยท FWM Prosthesis, Breast, Inflatable, Internal, Saline
Inamed Corp
Style 363 Saline-Filled BIOCELL textured Breast Implants
| Date | May 25, 2005 (initiated May 5, 2005) |
| Status | Terminated |
| Reason | Wrong size implant was mislabeled. |
| Root cause | Employee error |
| Action | Firm sent letter by overnite mail on May 5, 2005. Follow-up phone calls were made to confirm reciept. Doctors are to review surgery records and evaluate ammount of saline used to determine the risk for folding occuring and if found a visit by the patient is recommended to further evaluate for folding. |
| Quantity | 6 |
| Distribution | WI, TN, TX, NY, AR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.