Style 363 Saline-Filled BIOCELL textured Breast Implants
This recall has been terminated (originally issued May 25, 2005).
- Company
- Inamed Corp
- Recall Initiated
- May 5, 2005
- Posted
- May 25, 2005
- Terminated
- September 2, 2011
- Recall Number
- Z-0851-05
- Quantity
- 6
- Firm Location
- Goleta, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Wrong size implant was mislabeled.
Distribution
WI, TN, TX, NY, AR
Lot / Code Info
UF6328, UF6330, UF6331, UM5056, UM5057, UM5059
Root Cause
Employee error
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.