Style 363 Saline-Filled BIOCELL textured Breast Implants
FDA device recall Z-0851-05 · posted 2005-05-25 · Terminated
Recall details
- Recalling firm
- Inamed Corp
- Reason for recall
- Wrong size implant was mislabeled.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FWM
- Quantity affected
- 6
- Distribution
- WI, TN, TX, NY, AR
- Date initiated
- 2005-05-05
- Date posted
- 2005-05-25
- Date terminated
- 2011-09-02
- Location
- Goleta, CA
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