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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmSeptember 12, 2003
Date PostedOctober 15, 2003
Recall Status1 Terminated 3 on March 07, 2012
Recall NumberZ-0006-04
Recall Event ID 27294
PMA NumberP910044 
Product Classification Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled - Product Code FTR
ProductMcGhan Style 40, Round Breast Implant, Standard Projection, Silicone-filled Smooth INTRASHIEL Barrier Catalog Numbers: 25-40401 25-40461 25-40501 25-40561
Code Information Serial numbers are too numerous to include.
FEI Number 2024601
Recalling Firm/
Manufacturer		 Inamed Corp
71 S Los Carneros
Goleta CA 93117
For Additional Information ContactMorris Sherwood
805-683-6761 Ext. 4640
Manufacturer Reason
for Recall		The 400cc, 460cc, 500cc and 560cc sizes of the McGhan Style 40 Silicone-filled Breast Implants were manufactured using one size smaller shells than required.
FDA Determined
Cause 2		Other
ActionRecall was by letter to surgeons on 9/12/2003 which ask for return of unimplanted devices and an accounting of what is to be returned.
Quantity in Commerce694
DistributionNationwide and Canada.
Total Product Life CycleTPLC 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.
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