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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 FirmAugust 01, 2003
Date PostedSeptember 11, 2003
Recall Status1 Terminated 3 on September 10, 2003
Recall NumberZ-1216-03
Recall Event ID 27022
Product Classification Prosthesis, Breast, Inflatable, Internal, Saline - Product Code FWM
ProductMcGhan Round Breast Implant, Saline-Filled BIOCELL textured. McGhan Shaped Breast Implant Saline Filled BIOCELL textured.
Code Information 27-168391 27-363170LF
FEI Number 2024601
Recalling Firm/
Manufacturer		 Inamed Corp
71 S Los Carneros
Goleta CA 93117
For Additional Information ContactPatrick J. Crotteau
805-692-5400
Manufacturer Reason
for Recall		Labeling mixup.
FDA Determined
Cause 2		Other
ActionImplants were requested back by telephone. They were returned at the firm''s expense. Recall is complete.
Quantity in Commerce4
DistributionTenessee.
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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