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Class 3 Device Recall McGhan Style 468380cc SalineFilled BIOCELL textured Breast Implants |
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Date Initiated by Firm |
December 14, 2005 |
Date Posted |
December 31, 2005 |
Recall Status1 |
Terminated 3 on January 29, 2007 |
Recall Number |
Z-0336-06 |
Recall Event ID |
34256 |
PMA Number |
P990074 |
Product Classification |
Prosthesis, Breast, Inflatable, Internal, Saline - Product Code FWM
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Product |
McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
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Code Information |
Lot#1121360, Serial#11567825, 11567826, 11567827, 11567828, 11567829, 11567830, 11567832, 11567833, 11567835, 11567836, 11567838, 11567839, 11567840, 11567841, 11567842, & 11567843. |
Recalling Firm/ Manufacturer |
Inamed Corp 71 S Los Carneros Rd Goleta CA 93117-5506
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For Additional Information Contact |
Patrick J. Crotteau 800-624-4261 Ext. 4802
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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.
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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.
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Quantity in Commerce |
18 |
Distribution |
Nationwide |
Total Product Life Cycle |
TPLC Device Report
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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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PMA Database |
PMAs with Product Code = FWM and Original Applicant = Allergan
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