U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
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.
조치
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.