Inamed Corp McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380
Brand
Inamed Corp
Lot Codes / Batch Numbers
Lot#1121360, Serial#11567825, 11567826, 11567827, 11567828, 11567829, 11567830, 11567832, 11567833, 11567835, 11567836, 11567838, 11567839, 11567840, 11567841, 11567842, & 11567843.
Products Sold
Lot#1121360, Serial#11567825, 11567826, 11567827, 11567828, 11567829, 11567830, 11567832, 11567833, 11567835, 11567836, 11567838, 11567839, 11567840, 11567841, 11567842, & 11567843.
Inamed Corp is recalling McGhan Style 468-380cc Saline-Filled BIOCELL textured Breast Implants, Catalog Number:468-380 due to 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 fo. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026