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U.S. Department of Health and Human Services

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

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  Class 3 Device Recall McGhan Style 163360cc SalineFilled BIOCELL textured Breast Implants see related information
Date Initiated by Firm December 14, 2005
Date Posting Updated December 31, 2005
Recall Status1 Terminated 3 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
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 2
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 and Original Applicant = Allergan
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