Class 3 Device Recall McGhan Style 163360cc SalineFilled BIOCELL textured Breast Implants

• Date Initiated by Firm: December 14, 2005
• Date Posted: December 31, 2005
• Recall Status: Terminated on January 29, 2007
• Recall Number: Z-0337-06
• Recall Event ID: 34256
• PMA Number: P990074
• Product Classification: Prosthesis, Breast, Inflatable, Internal, Saline - Product Code FWM
• Product: McGhan Style 163-360cc Saline-Filled BIOCELL textured Breast Implants, Catalogue Number :163-360
• Code Information: Lot#1121514, Serial# 11567927 & 11567935
• 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 Ext. 4802
• Manufacturer Reason for Recall: Two lots of products were mislabeled; a lot of twenty Style 468 Breast Implants and a lot of twenty Style 163 Breast Implants. In error, the labels for these two lots were switched during packaging. As a result, a total of 40 devices were mislabeled.
• FDA Determined Cause: Other
• Action: On Wednesday, 14-December-2005, Inamed began calling affected customers to notify them of the voluntary recall. At the end of business on Wednesday, 14-December-2005, Inamed distributed Recall Notification Letters via Federal Express overnight mail directly to affected customers.
• Quantity in Commerce: 2
• Distribution: Nationwide
• 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