Class 2 Device Recall

• Date Initiated by Firm: May 05, 2005
• Date Posted: May 25, 2005
• Recall Status: Terminated on September 02, 2011
• Recall Number: Z-0851-05
• Recall Event ID: 32063
• PMA Number: P990074
• Product Classification: Prosthesis, Breast, Inflatable, Internal, Saline - Product Code FWM
• Product: Style 363 Saline-Filled BIOCELL textured Breast Implants
• Code Information: UF6328, UF6330, UF6331, UM5056, UM5057, UM5059
• FEI Number: 2024601
• Recalling Firm/ Manufacturer: Inamed Corp; 71 S Los Carneros Rd; Goleta CA 93117-5506
• For Additional Information Contact: Patrick J. Crotteau; 800-624-4261
• Manufacturer Reason for Recall: Wrong size implant was mislabeled.
• FDA Determined 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 in Commerce: 6
• Distribution: WI, TN, TX, NY, AR
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = FWM